Senior Engineer, Quality Resume Samples
4.8
(105 votes) for
Senior Engineer, Quality Resume Samples
The Guide To Resume Tailoring
Guide the recruiter to the conclusion that you are the best candidate for the senior engineer, quality job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.
Craft your perfect resume by picking job responsibilities written by professional recruiters
Pick from the thousands of curated job responsibilities used by the leading companies
Tailor your resume & cover letter with wording that best fits for each job you apply
Resume Builder
Create a Resume in Minutes with Professional Resume Templates
CHOOSE THE BEST TEMPLATE
- Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS
- Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES
- Instantly download in PDF format or share a custom link.
MR
M Rippin
Marilie
Rippin
12128 Watsica Mountain
Los Angeles
CA
+1 (555) 417 8785
12128 Watsica Mountain
Los Angeles
CA
Phone
p
+1 (555) 417 8785
Experience
Experience
Houston, TX
Senior Engineer Quality
Houston, TX
Wyman-Funk
Houston, TX
Senior Engineer Quality
- Develops, implements and maintains in coordination with other areas (purchasing, materials, Engineering) supplier quality programs
- Communicate essential Management review data to Plant QA Manager such as NCR, CAPA and Complaint trending and analysis
- Participate and track all process and/or equipment related corrective actions utilizing best and established problem resolution methods/practices
- Participates in the planning, development and transference of products and changes to materials, machinery or processes
- Coordinates the administration of quality systems including document development and updates of processes and records
- To handle wafer logistic and control the Qualification Hardware between wafer fab, testing and package house to meet project schedule
- Lead the technology maturity checking for new technologies and participate the spec optimization
Los Angeles, CA
Senior Engineer, Quality
Los Angeles, CA
Beier and Sons
Los Angeles, CA
Senior Engineer, Quality
- Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s
- Evaluates complaint trends and drives improvements. Investigates individual complaints
- Approves standard operating procedures; ensures procedures comply with policy and make sense
- Plan, define, monitor and improve the quality goals and targets for product and solutions
- Assist in the Annual Product Review Process in regards to FAR submissions
- Develops and implements statistical quality programs and process monitoring systems
- Maintenance and development of supplier, internal, and external audit programs
present
San Francisco, CA
Senior Engineer, Quality & Reliability
San Francisco, CA
Veum and Sons
present
San Francisco, CA
Senior Engineer, Quality & Reliability
present
- Writes validation protocols, perform or manage performance of protocols, analyse data and write validation reports (as assigned)
- Develop, update, and maintain technical content of risk management files
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
- Assist in development of short and long term quality goals and objectives globally
- Provide daily support to managers/staff regarding Document Change Requests and the Document Control System
- Ensuring the quality of the product design, manufacturing, application engineering services / solutions provided globally to customers
- Work in close collaboration with other product quality teams across the company
Education
Education
Bachelor’s Degree in Electronics Engineering
Bachelor’s Degree in Electronics Engineering
Hofstra University
Bachelor’s Degree in Electronics Engineering
Skills
Skills
- Strong organization skills. Excellent verbal and written communication skills
- Ability to handle multiple tasks simultaneously and ability to manage project timelines
- Technical: Strong data analytic skills, including statistical knowledge with hands on experience implementing and using statistical methods throughout various aspects of product realization including the use of critical tools in Production Parts Approval Process (PPAP), including FMEA, DOE, and GR&R methodologies
- Quality Management: Understanding of practical application of Cost of Quality model & driving metrics to reduce cost of poor quality integrated with practical experience in an ISO 9001/AS9100 based Quality Management System
- Computer: Proficient computer skills with office software applications and a proven ability to use basic data analysis tools
- Communication: Proven effective and advanced written and verbal communication skills to inform, explain, and where necessary, educate internal and external contacts on complex ideas related to quality issues. Demonstrated ability to write technical reports and presentations
- Professional appearance, team friendly, and approachable. A sense of humor
15 Senior Engineer, Quality resume templates
Read our complete resume writing guides
1
Senior Engineer, Quality Resume Examples & Samples
- Bachelor or Master degree in Electronics Engineering, Computer Science or similar
- At least 7-8 years of industry experience with hands on experience in software development, project management and implementing CMMI-DEV Level 3, Automotive SPICE (HIS Scope) Level 3, or ISO/TS 16949
- Responsible for facilitating quality processes, methodology and tools for IDC ( India Development center) engineering organization
- Provide support to IDC engineering groups in the setting up quality tools, metrics, processes and documents and define mechanisms to track and improve the same
- Perform internal audits to ensure compliance to the mandated quality process; Identify non-conformance and plans for improvement
- Ability to collaborate across multiple international teams for process improvement and standardization
- Skills for effectively managing geographically distributed teams involving multiple partners and engineering teams working on multiple programs
- English (business fluent)
2
Senior Engineer Quality Resume Examples & Samples
- Take care of compliance & product certifications for Honeywell Security and Fire manufacturing unit
- Handling of product certifications for UL, LPCB (EN Standards), CE, CCOE, SASO, ROHS, ATEX, CCC & FM
- Take care of third party audits – System & Product certification agencies
- Provide UL, EN & other standards requirement trainings within Organization
- Co-ordinate with third party certification agencies for day to day queries
- Lead auditor certified for ISO 9001:2015
- Handling of QMS for Honeywell fire & Security business
- Conduct internal audit program & QMS Overview trainings for new joinee
- Coordinate and drive Quality circle within organization
- Communicate the Quality policy, objectives & Statement with in Organization as and when needed
- Handling of Document change control
- Understanding and supporting to drive Kaizen, HSE,TQM & Poka- Yoke
- Use of lean six sigma tools for the analysis of business growth metrics
- Conduct the Management Review Meetings with higher Management as per the frequency defined
- Follow up corrective actions from customer feedback, CAR’s from Quality System audits and Quality problems detected during manufacturing
- Coordinate Problem solving through teamwork with all support departments
- Development, implementation and regular review of PFMEA and Quality Control Plans to assure continuous improvement of the Key business processes
- Participate in definition of Quality Criteria and assure their compliance in production areas
- Seek the elimination of waste caused by Quality Problems, applying lean manufacturing techniques and statistical tools
- Support productive areas in Quality Problems
- Support Incoming Quality activities by developing inspection standards for all new developments
- Be responsible for the analysis of returned product by the customer and send the corresponding report
- BE / BTech in Mechanical or relevant field
- Should have total working experience of 3~5 years
- Proficiency with Microsoft Excel spreadsheet and analysis
- Lead auditor for QMS
- Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally)
- SAP/ERP knowledge will be an added advantage
- Six Sigma Green/Belt certified
- Important skills include management experience, strong interpersonal and communications skills, presentation skills and excellent statistical analysis ability
3
Senior Engineer, Quality Resume Examples & Samples
- 40% - Review procedures, purchasing documents, drawings, manufacturing travelers, process data, certifications for completeness and adequacy
- 5% - Generate inspection method sheet for inspectors
- 5% - Participate in customer audits and source inspections
- 10% - Perform other related duties as assigned
- 10+ years of experience in an aerospace manufacturing operation with certification to ISO9100
- Ability to work autonomously and make effective decisions
- Knowledge of various materials (Inconel, Aluminum, Composites)
- Knowledge of processes (heat treating, welding, NDT)
- Knowledge of inspection methods
- Knowledge of ISO, EAR, and ITAR standards and regulations
- Project management, time management, problem solving and organization skills
- Ability to work as an effective team member
4
Senior Engineer, Quality Resume Examples & Samples
- Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following
- Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products
- Analysis and review of concession requests
- Review and approval of change management activities
- Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation
- Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses
- Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections
- Proficiency in statistical methods and application
- Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise
- Assist in the development, responsible for review & approval of process and equipment validation/qualification
- Support manufacturing transfers to other plants/facilities, leading quality activities
- Responsible for initiation, management and support of Ship, Product Holds, potential product escapes
- Coach and mentor others in quality topics and activities
5
Senior Engineer, Quality Resume Examples & Samples
- Collaborate with the R&D and Manufacturing teams to help facilitate successful execution of the NPD process and launching of robust products. Provide competence in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, Equipment Qualification, Process Development, and Statistical Techniques
- Leverage strong technical and collaboration skills for quality engineering related to support of Operations, product development, new product introduction, and process development (both internal and external)
- Resolve Manufacturing and Compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools
- Lead test method development/validation activities
- Facilitate Risk Management process in compliance to appropriate external standards and corporate policies. Provides technical support to NPD teams in generating risk files for new products
- Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives
- Partner with Manufacturing Engineers to develop/validate manufacturing processes and provide technical quality support for the production of clinical devices
- Lead failure investigations for product failures encountered during the New Product Development
- Maintain an up to date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques. Maintains an up to date knowledge of the company products, policies, and procedures
- Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures
- Bachelor’s degree in engineering and a minimum of four (4) years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience
- Strong organization skills. Excellent verbal and written communication skills
- Ability to handle multiple tasks simultaneously and ability to manage project timelines
- Must be accurate in handling detailed information/data
6
Senior Engineer Quality Resume Examples & Samples
- Responsible for developing, implementing, maintaining and measuring the effectiveness of the quality system including inspection systems, policies and procedures, testing measurements, non-conformances, corrective actions, customer complaints, training and internal audits
- Prepares and executes validation protocols of equipment and processes (IQ, OQ, PQ, MVP y TMV)
- Coordinates compliance of raw material inspection procedures and processes to assure quality requirements
- Develops and analyses process performance by comparing statistical data and acceptance criteria, seeking cost and cycle time efficiency assuring product quality and reliability
- Is responsible for innovating departmental technical systems, measuring system, and quality criteria adapting them to the organization and supervising their implementation
- Participates in the planning, development and transference of products and changes to materials, machinery or processes
- Ensure compliance of project activities to appropriate regulations and standards (FDA, ISO)
- Coordinates the administration of quality systems including document development and updates of processes and records
- Directly addresses failure analyses, non-conformances, corrective actions and customer complaints
- Minimize customer complaints due to product quality through effective Corrective Actions systems
- Initiates and directs Non Conformances Reports and Corrective Actions to problems relating to product or process quality
- Collaborates in continuous improvement programs, Lean Manufacturing, Six Sigma
- Develops, implements and maintains in coordination with other areas (purchasing, materials, Engineering) supplier quality programs
- Communicate essential Management review data to Plant QA Manager such as NCR, CAPA and Complaint trending and analysis
- Guarantees certification to his/her level
- Performs preventive audits to all production levels
- Identifies and analyses quality issues and proposes corrective actions
- Proposes product quality improvements, while observing maintenance or resale price reduction imperatives
- Executes quality engineering activities and functions for Devicor Medical Products de México. Participates in planning and implementation activities for new product introductions and transferences
- A key member of the Quality team. Implements and follows up on quality system procedures according to international norms (ISO13485, 21 CFR 820) and company policies
- Responsible for Compliance programs as it relates to new and existing products
7
Senior Engineer, Quality Resume Examples & Samples
- Ensuring the quality of the product design, manufacturing, application engineering services / solutions provided globally to customers
- Control the quality of materials purchased, processed, manufactured and distributed by the organization globally
- Plan, define, monitor and improve the quality goals and targets for product and solutions
- Play an approver responsibility on the quality and reliability of the new product design projects
- Must make key quality engineering contributions to product design engineering using a DFSS (Design for Six Sigma) process in new product designs
- Work in close collaboration with other product quality teams across the company
- 3 or more years in quality engineering, design engineering or manufacturing
- Must have a minimum of 3 year experience in direct interaction with customers
- Must be proficient in Microsoft applications
- Previous services experience is preferred
- Desired certification in LEAN, Six SIGMA Black Belt, CQM, AQE
8
Senior Engineer, Quality Resume Examples & Samples
- Identify and communicate product safety requirements to design team
- Participate in supplier assessment, corrective action, and audits
- Act as the quality representative for inspection and Material Review Board (MRB) activities
- Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc. Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis Contribute to formalizing and instituting the quality system, writing procedures, and utilizing quality tools and techniques to ensure product compliance to CE marking and QSR requirements Experience with generating technical files is preferred Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives Manage sterilization procedures and maintenance activities and the environmental monitoring program Participate in the SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities
- This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience. Minimum 5 years in a medical device industry. Extensive knowledge and experience in medical device development and manufacturing, from concept to release and distribution. Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601. Strong collaboration and development skills. Proactive, team player, enthusiastic, with high work ethics PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) High level of attention to details, capable of efficient use of time and project management skills essential
9
Senior Engineer, Quality Resume Examples & Samples
- Analyze Android based open source software using standard tools like Blackduck
- Generate Open Source (OS) compliance reports
- Monitor git/perforce repositories for changes, and ensure OS reports are updated
- Write basic Linux scripts to help in automation
- Guide Engineering teams on Open Source license practices
10
Senior Engineer Quality Resume Examples & Samples
- Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability
- Assures data availability and integrity for all quality related data. Consolidates and reports quality results
- Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products
- Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables
- Typically requires some knowledge of computerized electronic test equipment and programming
- Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations
- Ability to effectively communicate with managers and employees of the organizations
- Demonstrates advanced/thorough knowledge of the function and Flex business
11
Senior Engineer, Quality & Reliability Resume Examples & Samples
- Demonstrated technical and professional skill in job-related area required
- Generates technical solutions for current, new, and major programs
- Develops engineering designs
- Specifies and balances system requirements
- Communicates, coordinates, and consults with engineering departments and
12
Senior Engineer Quality Resume Examples & Samples
- Lead/Support all quality engineering activities to support production at Saxonburg Supply Center
- Provide focused quality engineering support to develop, support and maintain quality engineering methodologies that meets Customer, Regulatory and Bayer requirements
- Lead/Support the adherence to Quality Plans and Master Validation Plans for the implementation of new manufacturing technologies at the Saxonburg Supply Center
- Lead/Support MRB cross-functional team to investigate and address all manufacturing non-conformances
- Lead/Support investigation by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformance’s and manufacturing yields
- Lead/Support accurate and timely review of Device History Records (DHR’s)
- Lead/Support CAPAs and QIA’s to ensure effective closure of all actions as per the plan
- Lead/Support all change management, exception management and continuous improvement activities across the manufacturing plants
- Lead/Support manufacturing validation activities (IQ, PQ Test Method Validations)
- Identify, create, maintain and publish quality trends. Identify and implement opportunities to improve quality system and manufacturing processes
- Lead cost and quality improvement projects across Indianola and Saxonburg Supply Center
- Develop, implement and analyze process capability studies by using Statistical Process Controls (SPC) across all processes
- Provides leadership and coaches quality technicians supporting production
- Understands and applies knowledge of product line and clinical applications to work activities, and to support new products or processes
- Understands relevant processes required to accomplish objectives
- Bachelor’s degree in Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, Electrical Engineering or Plastics Engineering
- Proven ability to work collaboratively in a manufacturing environment
- Minimum 4 years’ experience working in high tech manufacturing environment providing direct manufacturing support
- Proven ability to demonstrate analytical capabilities (including designing and executing DOE’s, statistical analysis, analytical design tools etc.)
- Proven basic knowledge in application of quality engineering and risk management tools such as statistics, Six Sigma, FMEA and problem solving methodologies
- Proven ability to demonstrate strong project management and technical writing skills
- Knowledge of FDA QSR and ISO Quality Standards
- Strong competency in Bayer’s Core Competencies: Customer Focus, Drives Results, Instills Trust and Manages Complexity
- Proven ability to demonstrate at minimum Bayer’s Competencies: Collaboration, Courage and Plans & Aligns
- Experience with automated assembly of complicated disposable medical tube sets
13
Senior Engineer, Quality Resume Examples & Samples
- Ensure that all new products and changes to existing products and processes are formally validated, documents and approved prior to their implementation into routine production
- 8 years of demonstrated experience in Quality Engineering
- 5 years experience in Medical Device preferred
14
Senior Engineer Quality Resume Examples & Samples
- To manage cross function projects and drive team to meet project goals on schedule
- Participate and track all process and/or equipment related corrective actions utilizing best and established problem resolution methods/practices
- Follow-up on internal audits, CAR closure and ensure effectiveness in corrective actions implemented
- Support Quality System enhancement based on new technology needs
- Bachelor’s degree in Engineering or related field
- Master's degree in engineering or related field
- Experience in advanced technology manufacturing or developments
- Knowledge of advance technology manufacturing process
15
Senior Engineer, Quality Resume Examples & Samples
- Coordination of preparation and execution of inspections by regulatory agencies, consultants and third parties
- Maintenance and development of supplier, internal, and external audit programs
- QA investigator for nonconformance (NC) supplier investigations
- Present nonconformance (NC) supplier investigations to MRB and CRB
- Continuous assessment of the Regulatory Compliance environment and its impact on B&L Tampa Pharmaceuticals, to identify appropriate continuous improvement projects and/or CAPA
- Assist on activities related to any market actions, field alert reports and other regulatory actions
- Assist in the Annual Product Review Process in regards to FAR submissions
- Support review of Regulatory filings pre-filing and pre-launch
- Quality Management Systems Software programs as assigned
- Other tasks as assigned
16
Senior Engineer, Quality Resume Examples & Samples
- Critical review and approval of design changes, partner with R&D in the design of safe and effective THV devices
- Partner with Manufacturing Engineers to develop critical manufacturing processes and provide technical quality support for the pilot production of clinical devices
- Managing purchased component quality issues and working directly with suppliers
- Provide technical quality support for design qualifications, design transfer, activities for Regulatory submissions, development and implementation of design control documents, presentations for design reviews, and approval of product/process changes
- Minimum of 4 years’ experience in Quality or Manufacturing is required
- Knowledge of equipment qualification and design verification in the medical device industry or other regulated industries is required
- Must be able to work effectively and collaborate within cross functional teams
- Must possess the ability to handle multiple tasks with high attention to detail
- Quality engineering experience in new product development is preferred
17
Senior Engineer, Quality Resume Examples & Samples
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) through gowned-up and hands-on presence inside the clean room for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Requires close partnership with Manufacturing Engineering and Operations Supervisors
- Subject matter expert (SME) for responsible area within the overall manufacturing and assembly of pericardial tissue heart valves, including sewing, MRB and equipment, leveraging key knowledge of quality engineering principles
- Develop complex experiments and tests (including writing and executing protocols and/or test method validations) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
- Develop, update, and maintain technical content of risk management files
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work
- Train, coach, and guide lower level employees on routine procedures
- Bachelor's Degree + minimum of 4 years OR Master's Degree + minimum of 3 years OR Doctorate in Engineering or Scientific field + no experience, including either industry or industry/education required
- Strong knowledge in product and process development, PFMEA, control methods such as quality control plan development, critical control point identification, and work instruction development and validation. Experience with process or product transfer to alternate manufacturing sites preferred
- Ability to identify, interpret, and apply ANSI/ASQ Z1.4 And Z1.9 standards for attributes and variables sampling. Identify and distinguish between single, double, multiple, sequential, and continuous sampling methods
- Knowledge in selecting and describing appropriate uses of inspection tools
- Strong knowledge and demonstrated capability in using Quality Control Tools such as flowcharts, Pareto Charts, Cause and Effect diagrams. Demonstrates troubleshooting skills and capability in evaluating process changes and/or nonconformances for risk and developing technical justifications. Also includes demonstrated experience owning and managing a CAPA through its full lifecycle
- Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing
- CQE (Certified Quality Engineer) and Black Belt preferred (if applicable)
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Working knowledge and understanding of statistical techniques
- Previous experience working with lab/industrial equipment required
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Strong problem-solving, organizational, analytical and critical thinking skills
- Substantial understanding of processes and equipment used in assigned work
- Good leadership skills and ability to influence change
- Knowledge of and adherence to Quality systems
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
18
Senior Engineer Quality Resume Examples & Samples
- Lead / Support quality engineering activities to support production at Ohara Plant
- Lead / Support investigations by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformance’s and manufacturing yields
- Lead / Support projects associated with NPD,LCE and Product Supply
- Lead / Support validation activities and effective closures of CAPA’s QIA’s as per the agreed timeline
- Plan and manage work activities having significant technical scope with minimal direction and communicate comfortably at all levels of the organization
- Provide advice and mentoring to less experienced engineers or technicians
- Bachelor’s Degree in Software, Electrical or Systems Engineering
- 4+ years’ experience and recognized as an expert within a technical discipline
- Proven ability in software development using Visual Basic, C+, C++
- Direct experience within the medical device industry (FDA Regulated) and ISO 13485
- Proven ability in strong project management and technical writing skills
- Proven ability to demonstrate technical and analytical capabilities (including designing and executing DOE’s, statistical analysis, analytical design tools, IEC 60601-1 etc.)
- Experience using Lab view and Teststand
- Experience within ISO 62304
19
Senior Engineer, Quality Resume Examples & Samples
- Knowledge of ISO design control regulations and FDA design Control QSRs
- Work experience in medical device design control
- Must have working knowledge of and adherence to Quality systems, design control, and design verification/validation activities
- Strong working understanding of failure analysis, FMEA, specification development, quality/process control, acceptance sampling, and inspection/test methodologies
- Working knowledge and understanding of statistical techniques, reliability, and acceptance sampling
20
Senior Engineer, Quality Resume Examples & Samples
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
- Bachelor’s Degree in Engineering field and a minimum of 4 years related experience in medical device or pharmaceutical industry required
- Must have experience in manufacturing environment providing line support and experience with NCR’s/CAPA’s/TMV
21
Senior Engineer, Quality Resume Examples & Samples
- Product design: ensures verification and validation requirements are adequately addressed, ensures that new products are seamlessly integrated into the existing quality system. Develops validation strategy/Quality plans for projects. Guides team on proper components of IQ/OQ/PQ/PV activities
- Key participant in the design transfer process. Guides project team in development of design/process verification/validation plans. Evaluates current Quality System, and determines how new products will fit within system. Determines if any changes are required
- Leads teams to develop/update risk management files & PFMEAs for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures
- Manufacturing support: Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines
- Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action
- Provides routine analysis of performance indicators (yield, NCs, Complaints, etc.) and identifies trends. Presents this information to management, supervisors, and manufacturing operators. Leads initiatives to improve performance
- Post-launch maintenance: Evaluate proposed changes for design control requirements. Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria
- Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls. Uses relevant statistical tools to analyze data for proactive improvements. Ensures that decisions are made based on sound Quality principles and regulatory guidelines
- Evaluates complaint trends and drives improvements. Investigates individual complaints
- The Quality Engineer must be self-directed, and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System
- Writes validation protocols, perform or manage performance of protocols, analyse data and write validation reports (as assigned)
- Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria
- Provide daily support to managers/staff regarding Document Change Requests and the Document Control System
- Maintains electronic information including training, documents, scanning, deviations, DCRs and DCOs
- Support company goals and objectives, policies and procedures, quality systems, and FDA regulations
- The Quality Engineer must possess excellent written and verbal communication skills, and be able to guide others to make sound Quality decisions
- 6-8 years Quality experience, minimum 3 years’ experience in Medical Device and/or Pharmaceutical Industry
- Knowledgeable of ISO 9001/ISO 13485 and FDA/QSR requirements and quality system development and management
- Knowledgeable of other regulations desired
- Use of statistical techniques and application experience
- Training and experience in validation, auditing, statistics (ex. DOE, SPC)
- Strong written and oral communication and interpersonal skills
- Demonstrated project management and leadership skills, strong written and oral communication and interpersonal skills
- Working knowledge of FDA regulations and experience with managing external agency audits necessary
- Certified ASQ CQE and/or Lean Six Sigma Green belt preferred
- Training in problem solving tools is required (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis)
- Strong Computer & Information Technology Skills (Windows, Word, Excel, Access, Power Point, Project, Visio, statistical software usage & principles.)
22
Senior Engineer Quality Resume Examples & Samples
- Quality control tools such as: Histograms, Paretos, etc
- Software: MS Office, Minitab, etc
- Problem resolution tools: 8D, 5 why, etc
- Knowledge in AS9100 or ISO 9001 requirement
- 3 years’ experience in quality area minimum
- PPAP and APQP knowledge
- Experience developing control plans
- Lean manufacturing and Six sigma
- SAP
- Bilingual English Spanish
23
Senior Engineer, Quality Resume Examples & Samples
- Minimum of a Bachelor of Science degree in Engineering from an accredited university
- ASQ Certified Quality Engineer (CQE) and Lean Six Sigma certification is preferred
- Minimum of seven years work experience in an engineering role with increasing responsibility with practical application of Engineering principles in product development, supplier quality, and/or manufacturing quality engineering experience of electrical, mechanical, or electromechanical products
- Availability to travel up to 30%. Domestic and international travel
- Project Management: Proven complex project management and problem solving skills. Must be a critical thinker, able to “think outside the box”, and be an active listener with good time management skills and the ability to effectively multi-task
- Technical: Strong data analytic skills, including statistical knowledge with hands on experience implementing and using statistical methods throughout various aspects of product realization including the use of critical tools in Production Parts Approval Process (PPAP), including FMEA, DOE, and GR&R methodologies
- Quality Management: Understanding of practical application of Cost of Quality model & driving metrics to reduce cost of poor quality integrated with practical experience in an ISO 9001/AS9100 based Quality Management System
- Computer: Proficient computer skills with office software applications and a proven ability to use basic data analysis tools
- Leadership: Strong leadership, effective communication, accountability, and interpersonal skills. Must be a self-starter with a demonstrated ability to form and effectively lead, as well as collaboratively participate in, team activities with the ability to quickly learn new processes with very little information provided
- Communication: Proven effective and advanced written and verbal communication skills to inform, explain, and where necessary, educate internal and external contacts on complex ideas related to quality issues. Demonstrated ability to write technical reports and presentations
- Professional appearance, team friendly, and approachable. A sense of humor a plus
24
Senior Engineer, Quality Resume Examples & Samples
- Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
- Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments
- Participates on the Validation Review Board as the Manufacturing Quality Assurance function
- Approves standard operating procedures; ensures procedures comply with policy and make sense
- Approves calibration requests and ensures that these requests have appropriate product/process limits assigned
- Auditing of commissioning and validation documentation
- Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s
- Develops and implements statistical quality programs and process monitoring systems
