Quality Systems Engineer Resume Samples

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C Barrows

Conner

Barrows

6543 Hammes Row

Chicago

+1 (555) 682 8807

6543 Hammes Row

Chicago

Phone

p +1 (555) 682 8807

Experience Experience

Houston, TX

Quality Systems Engineer

Houston, TX

West-Koepp

Houston, TX

Quality Systems Engineer

Provide feedback to Test Engineering Manager & workcell manager on cost and cost trends
Support and provide technical assistance for the APQP Committee as well as in the development and maintenance of Process FMEA's and PPAP documentation
Assist with the development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
Work with site process owners to create, manage and analyze quality system metrics critical to measuring and tracking quality objectives
Assist operating units with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
Work with corporate, the OTT division and sites to create and drive improvements to QMS processes
Ensures the addition and management of any local QMS documents in line with the evolution of the Philips Quality Management System

Boston, MA

Quality & Systems Engineer

Boston, MA

Corkery-West

Boston, MA

Quality & Systems Engineer

Assist the Quality Assurance Manager in coordinating the development and implementation of activities related to Unimotion-Gear’s Quality Management System. Stay current on new quality initiatives and promote best in class benchmarking
In conjunction with the Quality Assurance team, Engineering and Production, participate in the development and improvement of process FMEA’s and Control Plans
Lead the team in 5 WHY analysis for any quality issues, and complete all sections of the 8D process
Work to continuously improve the quality of the product, and reduce scrap using A3 methodology
Ensure all internal audits are conducted in a timely manner, and that corrective actions are being implemented according to internal procedure
Ensure the active duties of maintaining ISO/IATF 16949 certification are achieved
Assist the management team in coordinating the development and implementation of activities related to the Division’s IATF 16949 quality system standards

present

Chicago, IL

Advanced Quality Systems Engineer

Chicago, IL

Bogisich, Sanford and Jacobi

present

Chicago, IL

Advanced Quality Systems Engineer

present

Ensure AQS process are carried out in all upcoming development projects in all development locations and plants
Standardization/harmonization of the AQS process and their integration into the JC valid AQS softwares in the PG/Plant
Controling + reporting of AQS process
Support FMEA, PFC & CP with interfaces between the customers assembly groups and the suppliers
Provides front line Risk analysis and Risk management support via FMEA – Quality Chain Work Instructions
Supports in Safety assessments according to Potential Product Safety Concern Work Instructions
Provides technical leadership by applying AQS /Advanced Quality Service/ Business Integration processes

Education Education

Bachelor’s Degree in Engineering

James Madison University

Bachelor’s Degree in Engineering

Skills Skills

Familiar with ISO 9001, Intel QOS+ System Elements or capable to drive Quality Operating System Element Gaps closure
Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues
Possess a broad knowledge of functional areas impacted by Quality Systems
Ability to follow SOPs and maintain quality standards
Comprehensive knowledge of quality systems and relationship to business
Strong attention to detail
Ability to lead team toward operational objectives
Has experience in writing protocols/validations and has fundamental knowledge of validation principles
Ability to adjust and prioritize work to meet deadlines
Ability to serve in leadership roles on projects or assignments

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15 Quality Systems Engineer resume templates

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Quality Systems Engineer Resume Examples & Samples

Drive efforts to enhance the Cisco Business Management System to better represent the goal of an unrivaled Customer Experience while maintaining relevance and value to the business
Employ structured quality & process optimization approaches (Six Sigma, LEAN, QFD, etc) to drive operational excellence and cross-functional systemic change based on audit findings and other process improvement efforts. Work cross-functionally across all Cisco organizations (such as Sales, Marketing, Engineering, CVCM, HR, IT and Services) to drive and enable systemic change management in business policies, processes, and programs. Leverage and promote best practices adoption company-wide
Perform internal audits across multiple functions and support the external audit process
Effectively communicate at all levels from Vice President to individual contributors to increase awareness and provide regular updates using voice, video and written means
Coordinate Business Management System-related activities to ensure consistent practices globally
Limited travel might be required to support these activities
BS Degree in a technical, business or related field. MS or MBA preferred
At least 8 years of strong proven program/project management skills with at least 10 years experiences in a fast paced, high technology environment
Strong background in cross-functional product development methodologies
Demonstrated experience in developing and deploying process improvements and best practices across organizational functions with a strong focus on results
Demonstrated strong presentation, communication, and teamwork skills with an ability to communicate with different audiences (staff to senior executives) and for different purposes (informational to persuasive)
Demonstrated leadership qualities including executive presence, ability to influence key stakeholders, and ability to execute thru direct extended teams
Ability to work with several organizations with differing needs and develop and implement an agreed upon solution. Be flexible to take on different roles/responsibilities as needs change
Demonstrated evidence of excellent leadership skills
ISO 9001 knowledge required and experience implementing ISO 9001 is highly desired
TL9000 & ISO 14001 industry experience a plus
Internal auditing experience a plus

V Mware Quality Systems Engineer Resume Examples & Samples

Collaborate with teams throughout VMware to identify potential quality misses and understand strategies to improve quality for our customers
Create project plans and coordinate timelines through internal and external development, QA and documentation resources
Manage projects, and establish, track and analyze project quality
Effectively influence teams to do the right thing for quality products though the use of sound analysis and data
Excellent written, verbal, and visual communication skills
Experience with Software Development Lifecycle and understanding the role of quality within it
Self motivated, independent, and works well within and across functional teams

Quality Systems Engineer / ts Coordinator Resume Examples & Samples

Work with the engineering group during product planning, design and development phases to assure that both economic and quality reliability goals are established and achieved
Responsibility to ensure that customer requirements are addressed. Including the selection of
Bachelors Degree in Engineering or related field preferred; or equivalent combination of education and work experience
Understanding of the complete quality management system
TS-16949 Lead Auditor Certificate preferred but not required
Minimum 5 years of diversified experience in Quality Management Systems/TS-16949 specific. in an automotive manufacturing environment
Demonstrated oral and written communication skills, as well as, strong organization skills
Personal computer skills
Understanding of manufacturing, assembly, sequencing and equipment principles
Normal amount of sitting
May be required to lift, push and/or pull 60 pounds
Average mobility to move around a manufacturing environment

Quality Systems Engineer Resume Examples & Samples

Be a key driver of cGMP practices within the Quality division
Provide support for the ISO13485 and 21CFR Part 820 Quality Systems
Maintain and follow up on CAPA, Internal Audit and other Quality Systems as required
Prepare metrics and reports on Quality System performance and present to Management
Be a primary contact for other departments providing quality advice / guidance to assure compliance
Become an active member of the site audit team, preparing for and participating in Corporate, Regulatory, Customer and Internal Audits
Prepare validation protocols as required
Provide a quality review on a range of quality documentation including Procedures, Policies, Specifications, Investigations, GMP records and other Quality Management System Documentation as required
Prepare and maintain documentation in compliance with the appropriate regulatory requirements
Periodically review quality systems and practices for improved efficiencies and to assure greater compliance

Quality Systems Engineer Resume Examples & Samples

Maintain the Internal Audit System and CMEU acting as the Quality Auditor with a team of Internal Auditors
Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations
Detailed knowledge of the Medical Device regulations, guidance and requirements
Ability to implement and improve a QMS
Organise and manage site preparation for Regulatory and Corporate Audits
Manage Audit back rooms for Regulatory and Corporate Audits
Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times
Conduct Supplier audits
Ability to lead and drive assigned Process Improvements essential
Prepare, implement and analyse key Quality Systems related documentation
Provide input and support to the Corrective and Preventive Action (CAPA) program
Provide training on the Quality Manual and other key Quality Systems procedures
Prepare Management Review presentations as appropriate
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner
Provide inputs to KPI's and Management Review
Ensure that Code of Conduct is considered in all business matters carried out
Third Level Qualification in Quality, Science or Engineering
Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry
Qualified and experienced Lead Auditor, preferably within the Medical Device Industry
Strong interpersonal skills with the ability to communicate effectively at all organisational levels
The ability to challenge thinking/opinion/actions in light of ensuring Quality Systems is adhered to
High attention to detail in all aspects of the role
Proven problem-solving skills
High self-motivation

Quality Systems Engineer Resume Examples & Samples

Leads the site complaint handling program for Class I, II & III IVD products including but not limited to evaluating, monitoring and investigating of customer complaints
Supports other site Quality Systems activities including but not limited to change control, training and internal audits
Ensures the quality system activities are in compliance with all applicable FDA quality system regulations as well as ISO 13485 and ISO 9001 in support of ASR, GPR, and IVD Class I, II and III products
Performs internal and external audits and supplier surveillance
Identifies and implements improvements to processes, products, systems, and customer related quality issues
Collaborates across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, find root cause, determine next steps, and create technical reports
Responsible for collecting data, performing moderately complex statistical analyses to investigate trends, provide interpretations, and draw conclusions at the site level
Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR)
Site specific software programs (change control notification program, CAPA, etc.)
Bachelor’s degree in biotech, science or engineering from accredited college/university or AA plus equivalent experience

Quality Systems Engineer Capa Resume Examples & Samples

Leads the site CAPA and change control programs
Provides training for CAPA, change control, root cause analysis and other investigational tools
Supports other site Quality Systems activities including but not limited to document control, training and internal audits as required by Quality Manager or Supervisor
Provides support for customer and Regulatory audits and inspections
Supports day-to-day site-specific quality needs for various, moderately complex products or product families. Examples include responding to non-routine quality complaints (e.g. performance related failures)
Identifies and implements improvements to processes, systems, and customer related quality issues
May provide guidance or direction to other lower-level personnel such as assistance with prioritization and investigations
Bachelor’s degree in biotech, science or engineering from accredited college/university
Minimum of 3+ years related experience in Medical Device or Pharmaceutical Industry
Class II/III IVD complaint handling experience
Masters of Science in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline preferred and/or MBA is highly desirable
Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr)
Experience with Trackwise, Agile, E1/SAP is a plus
IND-LSG

Quality Systems Engineer Resume Examples & Samples

Provide quality training to instill a quality minded culture
Lead structured team problem solving efforts (Six-Sigma, 8D, and Corrective/Preventive Action Reports) to resolve internal/external issues
Actively participate as a member of PROLaunch New Product Development Teams to bring new products to market when required
Lead change management activities within the facility
Lead / participate on cost-out teams
Improve supplier/customer relationship through effective partnering and communication
Support the training in order to develop technicians or operators as required
Support the MESH Initiatives and Zero culture
Support the Eaton Quality Systems as well as EBE, ISO/TS, etc
Support and/or participate on Continuous Improvement Activities such as: Kaizen, Ideas Programs, cost out and/or demonstrate improvements in goals year over year in our processes or practices aligned to achieve or business goals and/objectives
Bachelor’s Degree in Technical Field with lean manufacturing experience, preferred
3-5 years of experience in the same position preferred
Expert in lean manufacturing system including training, planning and implementation of tools
Position requires strong analytical skills and understanding of problem solving tools/methods (six sigma, 8D, QOS and other) and Balanced Scorecard goal setting process
Understands role of quality and variation reduction in driving operational improvement (minimum of Green Belt in 6Sigma, preferred)
Understands supplier quality, tools associated with new product development and launch, quality function deployment, quality management systems (QS, TS) and cost of quality
Understanding of budgets and cost drivers
Strong communication skills and comfort with facilitating teams/groups and working with all levels in the organization
Strong computer skills (MS Office, Project, etc)
Bilingual English-Spanish (100%)

Quality Systems Engineer Resume Examples & Samples

Experience with performing quality systems engineering, test and evaluation, and verification and validation for launch vehicle components
BS degree in Mechanical Engineering required
Experience with risk management
Experience with engineering drawings and engineering design software
Knowledge of current expendable launch systems

Quality Systems Engineer Resume Examples & Samples

Develop and maintain audit functions (product, process, and operating system) ensuring quality systems and products are consistent with internal documentation, standards, and customer requirements
Track, report, and promptly escalate Customer Complaint (8D) report status and ensure closure of corrective actions within timing goals
Gather Quality Management Review materials from cross functional department to timely meet its frequency
Support Supplier Audit, supplier survey, any supplier relevant activity and ensure closure and completion of SCAR database
Generate, analyze, and report on the levels of product quality within the assigned manufacturing areas, including Pareto, Statistical Process Control, and Process Capability Studies
Develop, analyze, and report statistical data, relative to quality systems performance and implementation, ensuring customer expectations are maintained
Support failure analysis process, ensuring feedback and corrective action communication and implementation is consistent with customer expectations
Participate in material disposition decisions and review the status of blocked stock materials for the timely implementation of material disposition decisions
Project management and leadership skills with an ability to collaborate with cross functional departments such as R&D, Product Management, and Process Engineering
Familiar with ISO 9001, Intel QOS+ System Elements or capable to drive Quality Operating System Element Gaps closure
Experience with implementing Six Sigma, Statistical Process Controls, FMEA, process audits and other proactive quality management practices
Microsoft Office and ERP systems skills

Body Quality Systems Engineer Resume Examples & Samples

Minimum of a Bachelor of Science degree in Mechanical or Electrical Engineering or equivalent from an ABET accredited university
Minimum of 1 year of experience working on body systems in specific body forward lighting, wipers and vision systems, rear lighting systems, exterior trim or functional plastics
Master's degree in Engineering, Quality, Business or equivalent from an ABET accredited university
Reactive Shainin Green/Black Belt certification
Proactive design for Six Sigma (DFSS) Green/Black Belt certification
Proven problem solving experience leading projects
Proven ability to deliver in fast paced work environment with minimum assistance

Quality Systems Engineer Resume Examples & Samples

Create and/or validate training curriculum in area of responsibility
Review and analyze field and manufacturing line component failures, and corrective actions; feedback to engineering; generate pareto and trend charts; drive corrective actions
Coordinate and generate failure analysis and corrective action reports for component issues
Review and guide component reliability testing, provide technical assistance in the testing and checking of assigned parts specialized fields such as physical, functional and environmental testing
Work with quality, production, manufacturing, suppliers and subcontractors to discuss and resolve quality aspects of specialized parts, materials and assemblies
DPM expectations are clearly communicated to the supply base
Communicate changes in Jabil DPM expectations on a timely basis
Provide communication forum for the exchange of ideas and information with the Worldwide plant quality and functional management departments, associated with new quality initiatives (process control tools)
Organize verbal and written ideas clearly and use an appropriate business style
Prepare and present customer presentations related to quality improvement initiatives
Assess communication style of individual team members and adapt own communication style accordingly
Define, develop and implement Quality Engineering strategies, which contribute to the campus strategic directions
Provide regular updates to Quality Engineering Manager on the execution of the strategy
Identify creative ways to reduce cost by streamlining processes and systems (i.e. modification of responsibilities or consolidation of tasks, elimination of non-value-added processes, or complete re-engineering of processes and systems)
Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value
Provide feedback to Test Engineering Manager & workcell manager on cost and cost trends
Review all supplier discrepancies. Coordinate and track the corrective/preventative action effort
Participate in the vendor survey activities as applicable. Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts
Interface and provide technical support on component quality issues with the customer as needed
Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor
Comply and follow all procedures within the company security policy
May perform other duties and responsibilities as assigned
Three to five years experience
Experience with integration and implementation of MES processes and tools/systems
Specific experience with implementation and use of RAD (Real time alerting DPMO software) is highly desirable
Experience with process mapping/improvement and requirements definition and analysis
Experience with definition and documentation of business requirements and system specification
Or an equivalent combination of education, training or experience

Advanced Quality Systems Engineer Resume Examples & Samples

Ensure AQS process are carried out in all upcoming development projects in all development locations and plants
Standardization/harmonization of the AQS process and their integration into the JC valid AQS softwares in the PG/Plant
Transfer experience from conducted analyses into all future projects
Technical Degree (Preferably Quality faculty)
Min. 1 year experience in Quality
Experience in Automotive Engineering
Knowledge of Quality Management
FMEA methodology and implementation
Fluency in English language

Quality Systems Engineer Resume Examples & Samples

Accomplish appropriately with the procedures of ISO-9001 updated version that applies
Support the diffusion of the Policy of Quality in the department
Internal Auditor
Coordinate activities in preparation to the internal and external audits of the Quality System
Manage all the updates of the Documents Control System through the Q pulse
Coordinate internal and external audits
Keep the reports updated of 3 Up’s, Warranties, QMs, Weekly Warranty Report, Security Report, daily report, etc
Control the approbation formats related to the Quality system
Coordinate the updates of the quality system ISO 9001/EQS to the updated versions
Coordinate the adequacy and/or creation of the procedures of the Quality System as a result of the improvement
Five years of experience at least related to quality manufacturing processes
Professional degree in Engineering (Electronics, Electromechanical, Industrial or related
Knowledge of blueprint reading, knowledge of the ISO9001 quality system current version, metrology, basic statistical

Quality Systems Engineer Resume Examples & Samples

Represents the Corporation, Division and Quality Department in a professional manner
Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required
Creates and reviews Quality System Documents
Creates and reviews Product Documents
Creates and reviews Test Methods
Creates/reviews Protocols, Process and Product Validations, Stability Protocols
Provides work direction as required
Creates and reviews documents required for Design History File
Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
Performs Internal or Supplier Quality System Audits
Ensures compliance to Department and Division procedures
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
Interfaces with manufacturing facility or other Division Facilities
Travels as required by the above duties and responsibilities
Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities
Strong Data Management and Report Presentation Skills
Advanced Microsoft Access and Microsoft Excel skills a must
Ability to create and qualify pivot tables, pivot charts, macros, queries, forms, reports, etc. across applications
Understands basic applied statistics
Has fundamental knowledge of validation principles
Comprehensive understanding of auditing principles; lead auditor experience a plus
Ability to participate on teams and maintain positive work environment with those teams
Good communication skills (verbal, written, and presentation)
Understands Basic Fundamentals of Engineering Principles
Ability to handle multiple task assignments
Ability to translate quality requirements into product specifications
Ability to interpret Regulations, Corporate, Division and Department Procedures
BS. in Engineering, Engineering Technology, Science a minimum
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
Minimum 5 years of experience with FDA regulated industry including 3+ years on product development programs

Quality Systems Engineer Resume Examples & Samples

Assist the location in preparing for 3rd party quality system registration audits and closing related non-conformances
Conduct internal quality audits
Participate in periodic management reviews of the quality operating system
Provide quality systems related training including internal auditor training
Assist the location in preparing for customer audits and closing related non-conformances. Respond to and complete customer quality evaluation surveys
Assist the location in the use and analysis of statistical methods such as control charts, capability studies, problem solving, Pareto Diagrams and other statistical tools for evaluating and reducing process variability
Support and provide technical assistance for the APQP Committee as well as in the development and maintenance of Process FMEA's and PPAP documentation
Update the Quality Manual and Quality System Procedures
Assist the location in maintenance of the supplier quality system
Bachelors of Science in engineering field from an accredited institution
Three years manufacturing experience, preferably in aluminum rolling
Lean Six Sigma Green Belt certification
Knowledge of statistical analysis programs (e.g. Minitab)
Must have strong communication skills and ability to communicate with all parties – customers, vendors, colleagues, superiors, etc
Experience maintaining the Quality (ISO9001 or TS16949) standards for a manufacturing organization
Experience auditing to the ISO9001 or TS16949 standard

Quality Systems Engineer Resume Examples & Samples

Drive improvements to the quality system that ensures its suitability, adequacy and effectiveness
Lead customer quality improvement with a focus on specific customers
Provide day to day and on-call production and process quality support
Provide operational support related to issue resolution, product quality/risk assessment and product disposition
Provide management of document control, calibration, corrective and preventative action, non-conforming material and deviation and supplier quality processes. Schedule and conduct internal and external calibrations as needed
Update quality related test methods using statistical tools, conduct MSE's, DOE's, hypothesis tests, and process capability studies
Lead new hire quality orientation, support divisional quality and customer satisfaction
Provide support in customer, supplier and regulatory audits
Generate and provide quality metrics for management review
Other duties as deemed necessary
Facilitate problem solving and statistical control
Maintain and evaluate GFPT’s corrective action program

Quality Systems Engineer Resume Examples & Samples

Bachelor’s Degree required – degree/major in engineering or science highly preferred
Minimum 3 years of experience in a FDA regulated industry (medical device or pharmaceutical) is required
3 to 5 years of in a quality role required
Must be able to work independently and prioritize with little supervision
Experience in Post market regulatory, quality or compliance areas preferred
Familiarity with basic quality tools and techniques is required
Analytical and Critical thinking skills are required
Experience working with CAPAs in a regulated industry environment is required

Quality Systems Engineer Resume Examples & Samples

Manage Quality Systems for Global Electronics
Responsible for TS 16949, ISO26262 adherence and compliance
Responsible for successful maintenance of TS Certification
Coordinate ISO/TS activities in manufacturing locations and other related design centers for Global Electronics
Conduct VDA Audits at design centers and manufacturing locations for Global Electronics
Conduct Line Readiness Audits, PMA, and LPA as needed
Understand and ensure compliance of ZF TRW systems to customer requirements and business needs
Alignment of PMA, LPA across Global Electronics
Follow up and closure of any actions, open items involving cross functional teams as needed
Maintain Lessons Learned Read Across Database
Assist in problem solving activities across product lines to maintain customer satisfaction
Certified TS personnel well versed in AIAG, IATF (TS/ISO) requirements
Knowledge in VDA systems/ Requirements. Certified personnel Preferred
Experience in establishing and maintaining Quality Systems in Automotive environment
Knowledge in Shanin or RedX problem Solving techniques. Certified personnel Preferred
Electronics product knowledge or background preferred

Advanced Quality Systems Engineer Resume Examples & Samples

Ensure Quality Chain (consistency between Design Failure Mode and Effects analysis / Process FMEA / Control Plan) processes are carried out in all upcoming development projects in all development locations and plants
Standardization/harmonization of the Quality Chain process and its integration into the Adient valid software in the Product Group/Plant
Facilitation of Quality Chain process activities in the Product Group and plants
Controling + reporting of Quality Chain process
Support FMEA, Proces flow chart & Control Plan with interfaces between the customers assembly groups and the suppliers
Provides front line Risk analysis and Risk management support via FMEA – Quality Chain Work Instructions
Supports in Safety assessments according to Potential Product Safety Concern Work Instructions
Provides technical leadership by applying Quality Chain Business Integration processes
Ensuring effective communication with all management levels
Technical education (secondary school/ university)
Experience in Automotive Engineering is an advantage
Knowledge of FMEA methodology and implementation

Quality Systems Engineer Resume Examples & Samples

Bachelor’s degree in engineering from an accredited university
Minimum of 5 years’ experience of manufacturing experience
Minimum of 2 years’ experience with quality documents such as Gage R&R, PPAP’s, FMEA’s, Control Charts, Control Plans, SPC related reports and/and calculations
Minimum of 2 years’ experience with ISO/AS9100 quality systems
Minimum of 1 year experience with Internal Quality Systems Auditing
This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee

Quality Systems Engineer Resume Examples & Samples

Lead the Quality Management System at Philips Oral Health Care
Ensure that the Quality Management System is created in compliance with the appropriate Philips Policies, standards and regulations required by the products supported
Take a lead role in the Quality Management Planning activity of changes to ensure compliance, outsourcing and Philips programs
Provide Leadership in steering quality management systems activities with ownership of Quality Management System Management Review and creation process, Corrective/Preventive Action System, and document control and training integration
Act on required reporting to respective regulatory and notified bodies for such activities as site registrations, device licenses, changes in product types, changes in activities at the site, and changes in personnel
Manage Philips Quality Management System related deployments and implementations
Establishes and executes a transition plan for all QMS related activities in scope while maintaining compliance and effectiveness throughout the duration of the transition to the Philips Quality Management System
Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the Philips Quality Management System transition
Ensures the addition and management of any local QMS documents in line with the evolution of the Philips Quality Management System
Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary
Managing site CAPA program and leading CAPA Review Board meetings
Establishes the Philips CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based designed tool for the CAPA system. Work on validation test protocols, conversion/migration of data, mapped configuration requirements mapped to corresponding regulation requirements as applicable for 21 CFR Part 11 and 820
Ensures proper CAPA planning and schedule meets the requirements of internal policies and external regulations

Quality Systems Engineer Resume Examples & Samples

Assists in manufacturing quality systems, product quality and customer quality requirements. Supports product improvement projects (validation IQ, OQ, PQ activities) and supplier changes to ensure qualification are met
Completes or may lead teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including six sigma may be required
Conducts risk analysis as needed. Conducts internal or external audits as assigned to ensure compliance to company quality system requirements
Develops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended use
Key contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards
Maintains records to ensure compliance to GMP/ISO requirements

Engine Systems Quality Systems Engineer Resume Examples & Samples

Bachelor of Science degree in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
3 years of experience in automotive Engineering, Manufacturing, or Quality
Master's degree in Engineering, Quality, Business or equivalent from an ABET accredited university (or equivalent)
3 or more years of experience working on Engine Systems in specific Fuel Systems, Cooling systems, Exhaust and Air Induction
Working knowledge of GD&T and tolerance stack-up analysis
Proven team leadership experience
Ability to engage and motivate the extended team members

Quality Systems Engineer Resume Examples & Samples

Create & maintain supplier contact database; plan for incorporation of this information into Master Control
Update supplier profiles for all Class C suppliers (may also include performance assessment of Class C suppliers). Evaluate profiles for A and B suppliers for compliance to procedure
Conduct standardized performance assessments with new “benchmark” template (assessments) and ensure minimum required information is submitted with the audit file (on-site audits)
Identify the need for and facilitate completion of memos (or other documentation) to address any existing gaps in the supplier files within the record retention period
Generate a database for existing/current supplier management documentation; generate electronic copies for backup/file storage; archive/facilitate off-site storage of physical files
Create and maintain audit management database (audit date, report date, AAP date, CA/PA due dates, completion dates, EV dates, closure date, etc.). Also include documentation of local SMC review and approval
Facilitate transition of paper-based to electronic-based systems (audit schedules, SCAR log, audit records (notification, agenda, executive summary, detailed summary, AAP, supplier profile, performance assessments, debarment checks, warning letter search, scorecards, memos, etc.)
Supplier Management Change Requests (Audit Schedule, ASL, SCAR log, etc.)
Identify linkages between supplier, material, specification, risk analysis; plan for incorporation of this information into Master Control
Expand report cards to entire ASL, also to include expansion of ASL (Internal Suppliers, non-inventory suppliers, consultants, contractors, etc.)
Reorganize ASL into three organizational categories – external BMD suppliers; external Shared Services suppliers; internal Bard suppliers. Possibly develop and include a fourth organization for DCO suppliers
100% audit of existing JDE vendors to assess services against requirements for supplier management program. Facilitate changes determined to be necessary as a result of the assessment
Organize physical filing system. Create physical “supplier files” containing items identified as standardize elements – i.e. audit/assessment (with all support documentation), agreements, profiles, scorecards, baseline memo for supplier classification, etc
Assist with documentation and communication associated with NCs, SCARs, AAPs, objective evidence
Develop into auditor in training, auditor, and lead auditor functions
Prepare reports for SMC meetings – Component Quality Rating, Audit Rating, SCAR Rating, Approval Status Rating, MRR updates, Audit updates, SCAR updates, Approval Status updates
Cross train in other QS responsibilities (R002, CAPA, metrics, etc.)
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information
Comprehensive knowledge of quality systems and relationship to business
Has experience in writing protocols/validations and has fundamental knowledge of validation principles
Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi
Ability to serve in leadership roles on projects or assignments
Comprehensive understanding of auditing principles and ability to perform as a lead auditor
Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies
Broad knowledge of manufacturing processes
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience
Understands Fundamentals of Engineering Principles
B.S. in Engineering, Engineering Technology, or Science a minimum
Minimum 5 years of experience with FDA regulated industry including 3 years in QA preferably Supplier Quality

Quality Systems Engineer Resume Examples & Samples

Bachelor's degree in related field required
A minimum of 6+ years related work experience required
Ability to lead team toward operational objectives
Aptitude to contribute to strategic goal-setting for department/business unit
Engineering experience in product development for medical devices
Experience and understanding pf IEC 62304, IEC 60601, and IEC 61010
Experience leading a team in the Design Validation and Verification phases for medical devices
Lead system-level definition, development, implementation, and launch of software-only and electromechanical and systems to deliver a valuable product to the end customer and meet the needs of multiple stakeholders
Collaborate with users and other stakeholders to formalize their needs and maintain formal systems for translating and maintaining the corresponding requirements
Proactively determine and manage other sources of systems requirements (e.g. regulatory standards, risk management processes, relevant industry standards, and business requirements) throughout the system lifecycle, engaging subsystem teams as needed
Define and manage the technical interfaces between complex surgical systems and future surgical tools
Lead the system architecture by managing requirements and partitioning of system, including between software (developed in-house and SOUP), hardware, and disposables
Manage and raise critical issues to resolve conflicts and minimize impact to program (cost, time, financial performance)
Partition systems into subsystems. Formally translate and manage apportionment of requirements and functionality among subsystems
Ensure appropriate change control processes and disciplines, ensuring that changes are appropriately reflected throughout system and subsystems
Allocate and integrate requirements for multiple disciplines (potentially including electronics, web-based and product software, firmware, etc.) while considering future needs for connectivity and upgrades (e.g. field upgrades, communications to other systems)
Lead and partner closely with all other system and subsystem teams to optimize the output of the system for the customer
Manage the resolution of cross-functional and cross-subsystem issues, tradeoffs, and risk in accordance with system objectives
Manage the integration and verification of subsystems in accordance with program requirements and design. Own the validation of the system against customer requirements

Quality Systems Engineer Resume Examples & Samples

3 years of relevant quality experience
Previous working experience in the automotive industry as a Quality Engineer
Mechanical / Industrial engineer or graduate in science, mechanical or chemistry is preferred
Working experience in the automotive industry as a Quality Engineer, especially handling German automotive customer
Able to work independently within the team
Keen interest in data analysis
Team spirit and social capabilities are important
Work diligently and accurately with a great sense for detail
Interested in projects that will support production processes and testing for product development

Quality Systems Engineer Resume Examples & Samples

Lead and provide infrastructure development support to the corporate business operating system
University degree in engineering or appropriate technical background in the quality management field
Trained/certified in standards for Quality Management Systems (QMS): ISO/TS16949, VDA 6.1, EAQF, AVSQ, EFQM
TS16949 Standard
Application of QMS tools and techniques
5 years work experience in the automotive industry and minimum 3 years on quality related activities

Quality Systems Engineer Resume Examples & Samples

Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics discipline from an accredited university
Minimum of three (3) years’ experience working in a quality systems engineering or quality engineering environment
Minimum of one (1) year experience working knowledge of International Organization for Standardization (ISO) 9001 standards
Master’s degree or higher in Engineering, Physics, Chemistry, Biology, Mathematics/Statistics or related discipline from an accredited university
Minimum of three (3) years of quality systems engineering or quality engineering experience
Experience leading cross-functional teams and/or projects
American Society for Quality (ASQ) certification: Quality Engineer (CQE) and/or Manager of Quality/Organizational Excellence (CMQ/OE)
Experience in the use of statistical tools
Lean Six Sigma training with proven ability to understand and apply Lean Six Sigma and other quality tools to product, systems and process problems
Experience in laboratory or product development
Experience in manufacturing
Test method development experience
Excellent communication skills (oral, written and presentation)
Established decision-making and problem-solving skills
Self-motivated with proven ability to apply innovative solutions to problems

Quality Systems Engineer Resume Examples & Samples

Update and continuously improve the QMS systems for compliance to current standards and regulations and customer requirements
Facilitate improvements of the QMS and provide training in the QMS and GMP
Lead the CAPA process ensuring corrective actions (CAPA) are completed in accordance with ISO requirements (incl. complete and compliant documentation) in a timely manner
Facilitate efficient and effective processing of CAPA’s and audit non-conformances
Host and follow up on external audits (Notified Body, Authorities, Customer Audits)
Act as project manager/representative on implementation of new Quality IT system
Represent the Roskilde site (Laboratory Products Division) in QMS improvements, and support quality and regulatory audits
Degree qualified in engineering or a related field from relevant discipline, or the equivalent knowledge and experience from the Life Science industry
3-5+ years’ demonstrable competence gained through successful experience from similar role, preferably with Medical Devices
Working experience with ISO 13485 & ISO 9001. Understanding of MDD, IVDD, US FDA 21 CFR part 820 is desirable
Solid experience as facilitator and influencer capable of translating and communicating complex information
Strong critical thinking skills with attention to detail without losing the greater picture
Organized, structured and decisive with the ability and willingness to work in ambiguous situations
Good strong communication skills in Danish and English adept with communication at all levels as well as with customers /stakeholders in a professional and effective manner
Committed and self-driven with a positive mindset, flexibility and persistence

Quality Systems Engineer Resume Examples & Samples

Serve as a resource and mentor for quality systems processes, requirements and compliance
Work with the OTT Director, Quality to serve as the primary divisional point of contact in CAPA, Audits, Metrics and Management Review
Work with site process owners to create, manage and analyze quality system metrics critical to measuring and tracking quality objectives
Coach staff on facilitation of thorough investigations from inception to closure
Work with corporate, the OTT division and sites to create and drive improvements to QMS processes
Assist with internal, external and corporate audits
Drive harmonization between OTT sites
Bachelor's degree (at a minimum) in a technical or scientific field
Quality certifications such as ASQ or Six Sigma certification is preferred
A minimum of 4 years’ experience working in a quality/compliance environment is required. Experience with cGMP, FDA regulations such as 21CFR820 and ISO series of quality standards such as ISO 13485 is required. Direct experience with FDA and/or Notified Body inspections/audits is required. Excellent organization and time management skills is required. Effective verbal and written skills including the ability to collaborate and communicate effectively with all levels of management are required. Ability to be proactive, self-motivated and prioritize and multi-task in a fast paced environment is required. Strong interpersonal skills, including persuasion, objectivity, assertiveness, and thoroughness is required

Quality Systems Engineer Resume Examples & Samples

Actively stays current with external and internal quality system standards and requirements
Providing Quality Systems support for the Galway site
Support QMS integration activity across the Galway site
Responsible for component complaint management
Responsible for complaint liasison with customers
Approvals as defined on Oracle
Co-ordinate water and product pyrogen testing as per agreed schedules & procedures
Identifies deficiencies in quality systems and defines systematic corrective actions
Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards
Coordinate Deviation process
Ensure compliance and drive improvements in QS processes
Assists in the preparation and maintenance of records associated with the management review process
Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned

Engine Systems Quality Systems Engineer Resume Examples & Samples

Minimum of a Bachelor of Science degree in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
Minimum of 5 or more years of experience in Automotive Engineering, Manufacturing, or Quality
Demonstrated ability to lead cross-functional teams
Experience working on engine systems in specific fuel Systems, cooling systems, exhaust and air induction
Demonstrated problem solving experience leading projects
Demonstrated team leadership experience
Demonstrated ability to engage and motivate the extended team members
Demonstrated ability to deliver in fast paced work environment with minimum assistance

Engine Systems Quality Systems Engineer Resume Examples & Samples

Bachelor of Science in Mechanical or Electrical Engineering from an ABET accredited university (or equivalent)
1 year of experience in automotive engineering, manufacturing, or quality
3+ years of experience working on engine systems in specific fuel systems, cooling systems, exhaust and air induction

X-ray Image Quality Systems Engineer Resume Examples & Samples

Providing domain expertise to serve as the main integrator between the hardware and software functions to deliver the best image quality in product
Developing methods to quantify subsystem interactions and their effects on image quality
Perform basic trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution. Conduct experiments and diagnostic tests, as required to draw conclusions
Demonstrated ability to make recommendations to technical and program leadership to improve the product, process or technology
Background in Image processing and algorithm configuration optimization for medical X-Ray images
Master’s or PhD degree in Physics, Electrical Engineering or other closely related fields
Proficient in using software tools to perform image processing algorithm design, image analysis and simulations

Advance Quality Systems Engineer Resume Examples & Samples

Function as Change Implementation Leader
Ensure effectivity dates are held for all changes
Ensure CR/CNs are initiated for Business Team business review and recommendations
Maintain Dashboards and Management reports for monitoring change status
Function as member of Task Team for development and launch of Team Center, APS Tool and Sharepoint site
Function as Advance Quality Engineer for new Valvetrain Program Launches
Participate in Project Team Meetings for Launch Programs
Facilitate closure for all open MQRR (Manufacturing Quality Readiness Review) deliverables
Facilitate closure for all SRV valves and PVM – Product Value Maps
Maintain Dashboards and Management reports for monitoring nonconformance status of program launch
Participate in Gate Reviews in the GCDP process
Supervise Clerical Support and oversee management of Standardized work Updates/releases
Facilitate timely releases of Standardized Work and minimize the use of PAA process to release standard work documents to the floor
Ensure proper accounting for any cost incurred when using additional contract personnel for updating/revising/creating standardized work documents and quality systems plant projects
Familiarity with Manufacturing process
Knowledge of GM quality systems and requirements
Demonstrated familiarity with GMS principles
Red X training with certified competency (any level)
High level of analytical ability for effective problem solving
Well-developed oral and written communication skills
Appropriate interpersonal styles and communication methods to work effectively with business partners to meet mutual goals required
Knowledge of and ability to effectively use computer software as it pertains to engineering and quality systems

Quality Systems Engineer Resume Examples & Samples

0 Function:Plans and directs the overall quality systems program for GKN Aerospace – Engine Products East. Identifies, researches, evaluates, and implements new technology projects throughout. Coordinates selected external and internal technology development
Duties and Responsibilities
Directs and coordinates ISO and other quality compliance certifications required by customers and government agencies
Manages the group’s quality resources to reduce defects and improve overall quality measurements
Investigates and implements quality process improvements throughout the group
Communicates and corresponds with customers to meet quality specifications and resolve issues, problems, and complaints
Identifies, evaluates, and assists with the implementation of new manufacturing technology projects with potential applications to one or more locations within the Sermatech Manufacturing Group
Oversees research on new products, materials, processes, and procedures to enhance and improve business offerings
Coordinates selected external and internal technology development and assists with the implementation of new technology projects within the group
Updates and prepares status reports on new technology developments to appropriate management, engineering, production, and sales personnel
Writes technical documentation as required
Represents SMG at appropriate technical conferences and makes occasional presentations
Identifies and solicits research and development funding from external sources
Chairs the “best practices” meetings within the SMG organization and represents SMG at Teleflex“best practice” programs
Manages SMG intellectual property issues and works with internal and external legal counsel when necessary
Prepares project schedules, budgets, and cost benefit analysis
Organizes and conducts technical training as required
0 Education and/or Experience Requirements

Quality Systems Engineer, Senior Resume Examples & Samples

Promotes and executes quality assurance philosophy throughout the organization
Conducts audits, both internally and externally, including the completion of customer matrices
Initiates and follows up on both internal and external corrective actions for root cause analysis
Responsible for creating and revising internal procedures
Solves problems, troubleshoots, and develops process improvements with other departments, suppliers, and customers as necessary
Plays an active role on quality management teams within the organization and keeps the management team abreast of significant issues or developments
Contributes and presents quality metrics during Management Review
Maintains a working knowledge of government and industry quality assurance codes and standards
Performs the investigation of Out of Tolerance Conditions (OOT’s) with calibration
Prepares and presents technical and program information to the management team
Supports in the implementation of APQP and PPAP
Contributes to team effort by maintaining a positive outlook
Complies with all company policies and procedures, including safety requirements
Other duties as assigned to ensure customer needs are met
Bachelor’s or Associate’s degree in Quality Engineering or technical field, or the equivalent work related experience
Certification as a Certified Quality engineer (CQE) or a Quality Auditor (CQA)
Two (2) years in a Quality Assurance role in a mechanical, manufacturing or aerospace industry
Working knowledge of AS9100C and root cause corrective action implementation
Working knowledge of Federal Aviation Administration (FAA) Part 21

Quality Systems Engineer Resume Examples & Samples

Develops and Executes quality audit plans in accordance with with AF, DoD, and commercial best practices, requirements, and policies
Applies application of modern quality principles and methods including: quality management system standards, producibility, process qualification/ validation, product design requirements flow down to manufacturing process requirements/ documentation, product and process controls, measurement and test, product/ process audits, statistical applications, configuration management, and lean manufacturing
Assesses, captures, and tracks certification quality engineering status, risks, and risk mitigation plans
Interfaces with on-site certification representatives to include USAF, Government, New Entrant, FFRDC, and other Government agencies
Applies company quality assurance requirements to all certification products, reports, and reviews
Reports to the Quality Engineering Lead on status of quality engineering activities and products
Other Duties as Assigned
8 years of experience with the development and application of quality assurance and engineering fundamentals and best practices applied to complex aerospace subsystems to include
Execution of QA and mfg audit plans
Conducting the audits from a quality assurance perspective
Performing quality risk analysis and identifying and developing mitigation plans
Participating in PDRs, CDRs, ERBs, and ChERBs with manufacturing support
BS degree in engineering, math, or physical sciences; will consider less experience in lieu of advanced degrees
Experience interfacing with computer-based database and schedule tools
Prior Air Force SMC or AFRL program experience

Quality Systems Engineer Resume Examples & Samples

The position recognizes that accident and injury prevention are equal in importance to production, quality, delivery, recovery and cost control. The incumbent accepts the responsibility to work safely, practicing and promoting safety consciousness through Arconic EHS standards and practices
Bachelors of Science degree in engineering from an accredited institution
Experience maintaining the Quality (ISO9001 or TS16949 / IATF 16949) standards for a manufacturing organization
Experience auditing to the ISO9001 or TS16949 / IATF 16949 standard

Quality Systems Engineer Resume Examples & Samples

Developing professional expertise, applies company policies and procedures to participate in the development, review, and improvement of the facility’s Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other FMCNA facilities
Utilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO). Maintains validation records and systems to keep ongoing process validations current and applicable to process
Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate, when appropriate, from current corporate documents
Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence
Uses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of negative trend. Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution
Reviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements
Participates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test, and that all calibration activities are performed when due
Participates as a member of the facility’s Audit Team in performing internal and external audits as required
Assists in providing in-house training (e.g., calibration, validations, batch production and operation of equipment) in conjunction with plant management to operators and other personnel, as assigned
Participates in product design control activities for new product lines
Conducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions
Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises
Normally receives general work instructions on routine work, detailed instructions on new projects or assignments
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action
Builds productive working relationships
Assists with various projects as assigned by direct supervisor
Minimum of 2-5 years of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a Master’s Degree no prior work experience may be necessary
Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong knowledge of Health Canada GMP’s
Must have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills. Knowledge of analytical laboratory methodologies is important
Professional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities
FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science certifications (i.e. ASQ, CQE, CMQ/OE) desired
Good verbal and written communication skills to make oral presentations and write technical reports

Quality Systems Engineer Resume Examples & Samples

Lead ongoing daily departmental activities for Hayward CAPA, Management Review, Change Control, Audits and FCA systems
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities
Lead site training for various quality systems; coach and mentor individuals and teams in root cause investigation and Quality System requirements
Serves as local administrator for electronic quality systems
Provide metrics for management review meetings and other platforms as needed
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills. Support process with timely closure of observations/audit items
Balance cost, quality, people and delivery objectives to meet plant strategic agenda
Other duties, tasks or projects as assigned
Team player with strong interpersonal/management skills
Excellent problem solving skills, attention to detail, verbal and written communication
Good project management skills
Working knowledge of FDA/ISO Regulations, Application of Good Documentation Practices, and Application of Good Manufacturing Practices
Bachelor’s of Science degree in Engineering
1-3 years of experience in Quality, or related field in the medical device industry
Must be experienced with interpreting quality system regulations. Audit experience is helpful, but not required
Six Sigma Green Belt desired

Quality Systems Engineer Resume Examples & Samples

Implements and the enforcement of ISO-compliant Quality Control procedures throughout the processes at Metal Coaters
Responsible for process quality and yield improvement activities on the Coil Coating Line
Assumes an active role with regard to ISO auditing and compliance activities
Performs daily analysis, disposition and management of non-compliant (HFI) material(s) diverted from the production process(s)
Tracks, manages and reports raw materials consumed on the coil coating line. This includes improving/eliminating the consumption of raw materials where possible, to reduce operating cost, without impacting the process or product liabilities of Metal Coaters
Analyzes process data via SPC methods, to validate or refine the Quality Control standards in place on the production line(s)
Develops and generates Process Control (KPI) and Product Quality/Performance reports as assigned
Calibrates and controls all product-measuring devices used by production employees to test and evaluate product at Metal Coaters
Assists the Quality Technician with reviewing, approving and ensuring the correctness of the process parameters designed into each incoming shop order to Metal Coaters
Performs all of the functions of the Quality Technician when called upon due to vacation, illness or other reason for absence
Responsible for understanding and complying with the fundamental principles associated with the Quality and Environmental Managements systems in place at Metal Coaters
Responsible for communicating daily with all levels of employees in order to assist in resolving problems and achieving company goals
Keeps equipment and work area clean and orderly
Ensure compliance with federal and state laws
Perform all duties in a safe manner

Quality Systems Engineer Resume Examples & Samples

Must possess thorough knowledge & understanding of the ISO9000 and/or AS9100 Quality Management Standards and their application to manufacturing industry
Demonstrated experience in auditing quality management systems and related operations within the manufacturing environment
Preferably experience in Lean Six Sigma processes & requirements
Technical knowledge of quality principles, quality assurance and quality control, process controls, &mechanical inspection techniques
Works well within the team environment &under pressure
Strong analytical skills
Strong priority & time management skills
Excellent verbal communication & writing skills
Ability to conduct process reviews and technical data package producibility reviews with suppliers & engineering teams
Ability to lead, coordinate, facilitate technical quality assurance activities among multiple teams
Ability to perform quality trend analysis, using failure history/reliability data, & identity key opportunities for improvement
B.A. Degree, Certification or License in a technical discipline or equivalent experience in the related technical discipline
Three (3) or more years of related experience and demonstrated ability to perform the essential functions of the job typically required
ASQ CQA preferred and other applicable certification desired
Previous or current DMIR license holder is an added asset

Quality Systems Engineer Resume Examples & Samples

Bachelor's Degree from an accredited institution
Minimum of 3 years of experience working in Quality Engineering role within a manufacturing environment
Bachelor's Degree in Engineering, Metallurgy, Metallurgical Engineering, Mechanical Engineering, Materials Engineering, or Material Science from an accredited institution
5+ years relevant work experience
Experience in the Aerospace manufacturing
Strong working knowledge and experience working with Quality systems and specifications
AS9100 specification experience is desired

Quality Systems Engineer Resume Examples & Samples

Use and maintenance of the ETQ Document Control module to maintain procedures
Be the Stafford Site Coordinate for ETQ Deviations to ensure deviations are routed to contributors for action
Develop the Quality Management System to support Operational Excellence, Lean, CAV and BIQ methodologies

Quality Systems Engineer Resume Examples & Samples

Bachelor’s degree in a scientific or technical field
3+ years of experience in the medical device industry
Working knowledge of GMP’s and other FDA regulations
Experience validating application activities
Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues
Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions
Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications
Proven analytical capabilities
Excellent communication, organizational and project management skills
Successful experience working with cross functional teams across multiple work locations
Effective written and oral communications skills and computer skills required
Network oriented and able to interact with different business functions and can work within numerous systems
Work cooperatively in a team environment

Quality Systems Engineer Resume Examples & Samples

Using “Quality” principles, implement and maintain a division wide continuous improvement quality system that ensures a high level of customer satisfaction combined with a low level of customer complaints
Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement
Responsible for creating audit plans and ensuring that quality systems and products are produced to Trinity Highway Products standards and specifications
Maintain and update key supplier audit system and schedule
Interaction with Supply Chain to monitor, communicate and improve key supply chain KPI’s, including Supplier OTD (Past due), DPPM and
Drive “Zero Defect” mentality within the supply base
Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
Establish specific short / long term supplier quality goals
Identify improvement opportunities and apply scientific methods, statistics and problem solving techniques to improve and sustain product quality and process effectiveness
Support the development and administration of the customer corrective and preventative action (CAPA)
Adapt six sigma methodology into process improvement, monitoring and analyzing data to identify non-value-added steps
Assist with the development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
Research and introduce innovative technologies to replace antiquated processes for better process repeatability and efficiencies
Compile & write training material and conduct training sessions on improvement tools & methodologies
Plan and execute projects and team activities to facilitate changes that have a statistical impact on business results, especially as it relates to meeting and exceeding customer expectations
Bachelor’s Degree in Quality, Operations, Manufacturing, Supply Chain or other related field preferred or equivalent experience and certification
Possess effective interpersonal skills in a team environment
Must be project-oriented and be able to multi-task
Knowledge/proficiency with Microsoft Office applications, including Microsoft PowerPoint, Microsoft Project, Excel, Visio and Word
Certified by the Society for Quality (ASQ) as a Certified Quality Engineer (CQE). desired
CQA (Certified Quality Auditor) status through ASQ (American Society for Quality) desired
Knowledge of various quality system methodologies 8D, Lean, 5 Why’s, Pareto Analysis, Six Sigma, 8-D, PFEMA, PPAP, preferred
ISO 9001:2015 knowledge preferred

Quality Systems Engineer Resume Examples & Samples

Bachelor in Industrial, Mechanical, or similar
3 to 5 years of experience within Automotive Industry or similar
Proven experience on QMS implementation (ISO/TS 16949, IATF 16949, VDA 6.3)
Proven knowledge of Automotive Regulations (IATF, AIAG, etc.)
Able to manage multidisciplinary teams
Hands on experience with Internal, External, and Third Party audits
Develops complex analysis of processes to identify systemic problems and solutions
Skills to evaluate processes effectiveness, risks and opportunities
Hands on knowledge on customer requirements and portals
Uses stablished guidelines, procedures and policies to meet objectives
Seeks for continuous improvement of the QMS
Promotes company values at all times
Develops his/her team members

Quality Systems Engineer Resume Examples & Samples

Develop, author, and release corporate Quality Management System procedures for the Medical Device industry
Support deployment of procedures in local entities' Quality Management System
Bachelor’s degree, preferably in a scientific discipline
Minimum of 7 years of experience working in Quality Systems supporting multiple functional disciplines within a global medical device industry
Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
Proven experience in creating and releasing Quality Management System procedures
A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance
Strong communication and writing skills with high detail orientation
Mastery of the English (US) language with an "affinity" for grammar
Strong knowledge of computers and Microsoft Office
This position requires extensive knowledge of FDA QSRs, ISO 13485, ISO 9001, and other worldwide Quality System Regulations

Quality Systems Engineer Resume Examples & Samples

4 year degree in an Engineering field
Ability to work effectively in cross-functional teams
Demonstrated project management and/or organizational skills
Working knowledge of MS Office, including Word, Excel, and Outlook
Experience in the medical device field
Experience in process verification and validation procedures
Experience with development analysis, evaluation, and testing of medical systems
Understanding of manufacturing and quality standards

Quality Systems Engineer Resume Examples & Samples

Provide direction and support for multiple company locations adopting changes to the global Quality System framework
Manage projects for QS CAPA in North America
Ensure alignment with corporate standards and CGMP guidelines as well as assisting in increasing reported quality metrics
Provide coaching and mentoring to global process owners through effective support of QMS
Collaborate with management from all sites to facilitate and ensure company practices are consistent and compliant
Facilitate meetings to engage global leadership on Quality System framework and initiatives
Create, maintain and utilize a “Standard Work” approach to perform tasks and produce deliverables needed to support teams, develop solutions and manage projects
Manage cross-functional teams to meet project plans including timelines and budgets
Support quality metrics: collect, maintain, trend, and analyze data
Collaborate across the organization at all functional levels and locations
Implement and Utilize tools to drive compliant and effective processes
Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, and other key performance indicators
Provide interpretations and training as needed
Subject matter expertise in Quality Systems for medical devices
Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical device development and manufacturing
Ability to organize complex information into meaningful structures appropriate for diverse audiences
Possess a broad knowledge of functional areas impacted by Quality Systems
Demonstrated track record of systematically improving global Quality Systems
Experience in leading cross functional teams
Project management skills, including: set priorities, analyze risks, and make appropriate judgments and decisions
Ability to work individually with minimal supervision and as part of team

Quality Systems Engineer Resume Examples & Samples

Bachelors Degree (BSE) or related degree preferred
A minimum 2 years of experience or related work experience is required
Additional experience may be considered in lieu of the educational requirements

Quality Systems Engineer Resume Examples & Samples

Reporting Research Results
Technical Understanding
Promoting Process Improvement
Developing Standards
Managing Processes
Manufacturing Methods and Procedures
Supports Innovation
Operations Research

Quality Systems Engineer Resume Examples & Samples

Provide QA support for pass-through product by handling customer quality concerns, issuing PPAP’s to the customer, working & communicating with the product manufacturing facilities, coordinating and managing product warranty activity & working with appropriate support departments in proper handling, disposition, and shipping of product
Oversee the training and communication of Hitachi Global Standards to the local staff to include oversight of training schedule, tracking and communicating revisions, conducting training sessions, communicating with HQ in Japan, and assisting in standard implementation in the organization
Provide oversight of the change management/APQP activities of product commodity teams to assure that internal and external requirements are met according to prescribed schedules. Activities to include
Supporting and communicating with cross-functional team members
Scheduling and leading routine meetings with cross-functional program team members
Maintaining records and minutes of team review meetings
Updating and managing any related APQP tracking spreadsheets and/or software for team communication and change implementation monitoring
Interfacing with customers and suppliers as needed
Assuring that the implementation of all product/process changes meet completion timing, product quality, documentation completion, and all related standards
Responsible for escalating to management any potential risks that would prevent meeting the above requirements
Participate on the Quality Systems Internal Audit Team
5-10 years experience in an automotive environment, familiarity with ISO/TS standards. Previous quality experience preferred
Must have experience in an MS Office environment. (Word, Excel, PowerPoint and Access). Moderate keyboarding skills needed
Familiarity and/or experience with Advanced Product Quality Planning and leading a project team
Requires good presentation and meeting management skills
Good organization, communication, and attention to detail is a must

Quality Systems Engineer Resume Examples & Samples

Provide quality systems support to Silgan's manufacturing facilities in order to enable process improvement and reduce variability
Lead our customer and vendor certification process
Establish and validate our process and product monitoring methodologies as well as review and evaluate our quality processes in our manufacturing facilities
Develop sampling plans, inspection procedures and SOP's for assigned customer groups
Bachelor's Degree; a degree in a technical discipline is preferred
At least 3 years prior experience in a manufacturing or quality role
ASQC - Certified Quality Engineer is preferred
Experience in Food Safety (GFSI) is highly recommended
This role requires the ability to travel at least 50% of the time, sometimes on short or little notice

Quality Systems Engineer Resume Examples & Samples

Provides Quality System Body of Knowledge support to organization
Investigates, and resolves system nonconformance’s (defined during internal and/or external audits
Develops QS related reports (i.e. Quality plans, reports, process documentation) to support business activities
Ensures compliance to ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and leads activities to implement improvements
As appropriate, utilizes quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in quality system compliance, device, and process
Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements
As appropriate, support teams in quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
As appropriate, support completion and maintenance of risk analysis, as related to quality systems
Support of core Quality System activities (e.g. Management Review preparation, External Standards, Org Responsibility, Quality Manual) to meet process requirements
BS degree in Engineering or Technical Field or equivalent experience
0-2 years’ experience
Engineering experience preferred
Knowledge of Quality tools/methodologies
Solid communication and interpersonal skills
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail

Quality Systems Engineer Resume Examples & Samples

Support the Global Internal Audit function through participation in Internal Audit community meetings and projects
Identify and lead continuous improvement opportunities in the Internal Audit function
Work with Internal Audit team, Global Internal Audit function, and other BSC sites to continuously improve approach to product and process focused audits
Participate within the Quality Systems team as a team member supporting various compliance initiatives, including one-off internal audit requests, mock audits, back-up external audit Subject Matter Expert, etc
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues
Bachelor Degree in the Engineering or Science field, plus 2-4 years of related experience or an equivalent combination of education and work experience
Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
Proficient and comfortable leading audits within a medical device regulated environment to criteria including external regulations 21 CFR Part 820 and ISO 13485
Easily and clearly communicates status updates and results of auditing activities to auditees throughout the internal audit process
Knowledge of additional external regulations, including 21 CFR Part 4, 21 CFR Part 11, ISO 14971, Medical Device Directive 93/42/EEC , Therapeutic Goods (Medical Devices) Regulations, MHLW Ministerial Ordinance No. 169, SOR/98-282, and RESOLUTION RDC Nº 16
Experience with CAPA, Management Review / Controls, and External Audits
Flexible and positive attitude
Computer literate, network knowledge required

Iatf Quality Systems Engineer Resume Examples & Samples

5 years minimum of Quality experience in a Manufacturing environment
Knowledge of automotive quality standards and tools including APQP, PPAP, FMEA, MSA, 8Ds, SPC
Experience in Automotive Industry requirements
ISO/TS 16949 experience and certification required. Lead Auditor preferred
Extensive experience leading Internal Audit activities
IATF Expert Certification a plus
CQE Certification desired
Bilingual (English-Spanish) 80%

Quality Systems Engineer Resume Examples & Samples

Responsible for coordinating and managing all external audits
Responsible for managing the site internal audit process
Responsible for managing the site internal CAPA process
Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis)

Quality & Systems Engineer Resume Examples & Samples

Assist the Quality Assurance Manager in coordinating the development and implementation of activities related to Unimotion-Gear’s Quality Management System. Stay current on new quality initiatives and promote best in class benchmarking
In conjunction with the Quality Assurance team, Engineering and Production, participate in the development and improvement of process FMEA’s and Control Plans
Lead the team in 5 WHY analysis for any quality issues, and complete all sections of the 8D process
Work to continuously improve the quality of the product, and reduce scrap using A3 methodology
Support Quality Management System by ensuring standards related to IATF 16949, GQS, MAFACT and Customer Specific Requirement are current and appropriately distributed
Develop the internal audit schedule and update as required
Ensure all internal audits are conducted in a timely manner, and that corrective actions are being implemented according to internal procedure
Ensure the active duties of maintaining ISO/IATF 16949 certification are achieved
Assist the management team in coordinating the development and implementation of activities related to the Division’s IATF 16949 quality system standards
Assist in the development of Quality Engineers in the proper use of Core Tools (FMEA, SPC, Control Plans, APQP, PPAP, MSA) etc
Lead Role in maintaining Customer Specific Requirements to maintain Q1, JLRQ, and BIQ rating
Perform lead auditor duties for QMS internal auditing including providing audit schedules, providing management with audit results, and leading in closing out corrective action issues
Ensure QMS customer requirements are made available to appropriate departments within Unimotion-Gear
Lead auditor duties for QMS internal auditing, including providing audit schedules, providing management with audit results and leading in closing out corrective actions issues
Data and document control for IATF 16949
Lead role in surveillance and registration audits for QMS including scheduling third party audits
Make all documentation available on the network and maintain one master hard copy as a contingency
Provide meaningful statistics to the Quality Manager in a timely manner to assist in continued improvement of workplace
Work with all other departments within UMG to carry out any engineering changes or quality procedure changes to ensure all instructions are continuously improved and current
Assist in responding to internally or externally generated non-conformances
Work as a team member and pass on skills, knowledge and/or understanding of Unimotion-Gear to new employees
Supports all plant IATF 16949 & ISO initiatives & requirements
Comply with the applicable responsibilities related to effective quality management in accordance with Unimotion-Gear’s Quality Management System (QMS) IATF 16949
Perform other duties as assigned by the Quality Assurance Manager
College Diploma in a quality related field
Certified Quality Engineer/Technician certification or equivalent required
Three (3) to four (4) years’ experience with quality systems and system auditing in an automotive manufacturing environment
Able to travel outside of Canada to customer and supplier sites when required
Demonstrated knowledge and understanding of automotive blueprint reading, dimensional measurement, advanced SPC, design of gauging, DOE, PPAP, APQP, PFMEA, IATF 16949
Lead auditor certified to ISO/ TS / IATF16949 requirements
Able to work overtime as required
Excellent ability to communicate and interact with people at all levels, both inside and outside the organization
Proficient in Windows, Word, Excel and Microsoft Outlook

Quality Systems Engineer Resume Examples & Samples

Working with existing users with use of the application
Creating and maintaining Work Instructions & Training Material for end-users and administrators alike
Development of robust promotion and product testing processes to ensure application reliability
Working with business users to assess and understand business needs
Developing functionality to support these business needs
Resolving issues within the application through use of problem-solving techniques, interaction with internal IT organization and vendor’s support system
Understand our customer requirements through use of Customer supplier portals
Maintain and develop SharePoint sites to support business needs, through
Interaction with stakeholders, assessment of needs determination and implementation of appropriate solutions
50%: Leading sites (manufacturing and distribution) through the implementation of Reliance for document control
30%: Providing support to existing sites with use of Reliance with user provisioning and training
20%: Participating in requirements gathering, design, configuration, testing and documentation of new modules within the application

Quality Systems Engineer Resume Examples & Samples

Internal IATF 16949 Audits – including audits conducted by Bosch Automotive Steering Germany
Customer Audits
Fulfill required responsibilities as the assigned Management Representative for the Bosch Automotive Steering Florence / Plymouth IATF 16949 QMS
Responsible for being the Primary Contact and Coordinator for the Audits and Audit Responses
Schedule the applicable Departments to be available for the Audits
Schedule and conduct meetings with Departments to review Audit Findings, Corrective Action Development, and Corrective Action Implementation
Verify effectiveness of the Corrective Actions by re-auditing the Corrective Actions several months after initial implementation of the Corrective Actions
Initiate changes / improvements to the Bosch Automotive Steering Florence / Plymouth QMS to ensure compliance to the IATF 16949 Standard
Review Bosch Automotive Steering Corporate Guidelines and Directives to determine applicability to ZFLS Florence / Plymouth

Quality Systems Engineer Resume Examples & Samples

Fully supports the AS9100 Project Manager in the
Analysis of in place quality management system
Authorship of necessary manual(s)
Revision of affected supporting documents
Implementation of the above and training of the workforce
Scheduling and hosting required audits related to the project
Driving corrective actions in response to those audits
Ongoing direction and maintenance of the quality system following implementation
Actively participates in and promotes continuous improvement initiatives as required to meet company targets in Safety, Quality, Productivity, and Cost
Other tasks as appropriate and as assigned by management
4 year degree in Engineering or science discipline
Two years of experience in the administration of AS9100 quality management systems or five years directly related experience
Ability to follow SOPs and maintain quality standards
Ability to adjust and prioritize work to meet deadlines
Strong communication, organizational and teamwork skills
Strong computer skills (Microsoft Office required)

Quality Systems Engineer Resume Examples & Samples

Analyses data outputs from processes to identify improvement opportunities (COS audits, systems audits, process audits, LPA’s, CAR / PAR)
Pro-actively identifies process and system improvements, develops improvement plans and leads implementation
Lead Continuous Improvement projects across the sites
Manages and develops systems and process audit functions within the plant. Constantly review the process to ensure continued effectiveness and identification of improvement opportunities
Lead the Integration of the transition to the new IATF standard from TS 16949
Maintain IATF Standards across the site to ensure re-certification status year on year
Experience working with TS16949, ensuring the whole site is adhering to the standard
Fully qualified (Degree/ HNC/HND)
Six Sigma qualified would be advantageous

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