Staff Supplier Quality Engineer Resume Samples

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L Feeney

Lavern

Feeney

310 Susanna Avenue

Los Angeles

+1 (555) 557 0339

310 Susanna Avenue

Los Angeles

Phone

p +1 (555) 557 0339

Experience Experience

San Francisco, CA

Staff Supplier Quality Engineer

San Francisco, CA

Kub, Hodkiewicz and Armstrong

San Francisco, CA

Staff Supplier Quality Engineer

Method Validation, Sampling Plans Development and Review, and Supplier Management and Certification
Continue to develop and improve the technical assessment process, including incorporating best practices and lessons learned
Disposition nonconforming material and develop tactics to eliminate it
Serve as a leader within the Supplier Quality Engineering Organization, providing guidance to other team members as necessary
Perform supplier audits on potential and current suppliers
Develop systems to ensure quality of purchased raw materials and finished foods
Maintain global processes that govern Counterfeit Risk Management

New York, NY

WW Staff Supplier Quality Engineer

New York, NY

Kuphal Group

New York, NY

WW Staff Supplier Quality Engineer

Support development and automation of supplier quality metrics which drive supplier improvement through targeted KPI performance
Continually assess the Supplier Management and QA Management system and SOPs for continual improvement
Develop and execute comprehensive quality strategies for design development, verification and validation
Performs other duties as assigned by management
Visit suppliers to resolve product performance & development timing concerns
Initiate and manage projects to improve quality, yields and value received from the supply base
Support various quality management system improvement projects

present

Boston, MA

Senior Staff Supplier Quality Engineer

Boston, MA

Conn, Morissette and Osinski

present

Boston, MA

Senior Staff Supplier Quality Engineer

present

Work with purchasing representatives to ensure Applied Technology supplier management processes comply with ISO 9001
Monitor supplier performance and report supplier quality trend data to management
Function as liaison between purchasing, engineering, manufacturing and suppliers to resolve supplier issues and to provide technical support
Request, develop and monitor supplier corrective and preventative action plans and activities as necessary
Determine cause of supplier problems and coordinate/implement effective and timely resolutions
Participate in the timely disposition of nonconforming material as it relates to supplier responsibility
Travel to supplier sites to resolve nonconforming material concerns

Education Education

Bachelor’s Degree in Engineering

Florida International University

Bachelor’s Degree in Engineering

Skills Skills

Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills)
Ability to work effectively in a team environment and build strong working relationships
Strong background and experience in NPI Quality for instrumentation hardware and qualification
Supports the development of quality engineering and quality compliance with the right skill sets for product life cycle management
Strong team player with ability to work effectively on cross-functional teams
Demonstrated ability and skills to support supplier development activities, continuous improvement initiatives and quality management tools
Develop systems to ensure quality of purchased raw materials and finished foods
Ensure effective risk management to prevent unanticipated failure modes and ensure capability
Strong analytical and problem-solving skills
Excellent communication skills; both verbal and written

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Staff Supplier Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's Degree is required; a degree in Engineering, Life Science, or related discipline is preferred
A minimum of 6 years experience in a GMP and/or ISO regulated industry is required, experience in the medical device and/or pharmaceutical industry is preferred
FDA and ISO regulations knowledge is required; FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
Auditing background is highly desirable
Experience and/or knowledge with machining manufacturing processes and injection molding are preferred
Six Sigma, Lean, or ASQ Certification and training are preferred
Experience with CNC Milling and Turning; Press Breaking and Punching, Assembly; Metal Laser Etch; Silk-Screen, and Metal Processing such as passivating, anodizing and heat treating are an asset
This position will be based in West Chester, PA, and will require up to 25% travel.Quality (Eng)

WW Staff Supplier Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical field is required
A minimum of 6 years of experience in data analysis, risk assessment and risk mitigation is required
Medical Device or Pharmaceutical industry experience is preferred
Quality Assurance experience is preferred
Quality Engineering experience is preferred
Knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) required
Knowledge of Non-Conformance Reports (NCRs) is preferred
Knowledge of Corrective and Preventative Actions (CAPAs) preferred
Process Validation experience in new product introduction is preferred
Project management experience is preferred
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required
Experience with Microsoft Visio is preferred
Experience with Microsoft Project is preferred
Experience with Minitab is preferred
Knowledge of Process Excellence tools (Lean, Six Sigma) preferred
Lean or Six Sigma Green Belt or Black Belt preferred
ASQ certification (CQE, CQA) is preferred
Must have strong business acumen
Must have the ability to collaborate will all levels of management in cross-functional team environment
This position will require up to 15% domestic and international travel

Staff Supplier Quality Engineer Resume Examples & Samples

Coordinate cross functional teams to assess supplier capabilities and opportunities for improvements by performing Technical Assessments of our suppliers (direct material and external manufacturers). Track findings (including appropriate effectiveness checks), ensure corrective actions are adequate and addressed in a timely manner and maintain quantitative and qualitative data that tracks the ongoing performance of the Enterprise supply base
Create executive summary and proactively communicate any risk identified during assessment, ensuring proper escalation to the business
Interacts and collaborate with the following teams on a regular basis: External Operations, Sourcing, Partner Development and Engineering, Compliance, Category Teams, and others as required
Ensure supplier performance is monitored, addressed and escalated as needed related to Technical Assessments
Ensure effective and efficient use of PE tools and Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control while performing assessments at our suppliers
Utilize technical expertise specific to applicable categories (ex. Plastics, API/Bio, Packaging, Chemicals, and Metals) to ensure robust assessments of suppliers and corrective action closure
Continue to develop and improve the technical assessment process, including incorporating best practices and lessons learned
Identify improvements to the technical assessment program based on the technical expertise of the processes and technologies being assessed
Train and mentor Senior Supplier Quality Engineers – Technical Assessments
At a minimum, a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science. Minimum of 4 years of experience in technical areas
Certified Quality Engineer and Certified Quality Auditor (ASQ or equivalent) preferred
Experience in the following categories are preferred: Plastics, API/Bio, Packaging, Chemicals, and Metal
Experience in performing audits and/or technical assessments is required
Experience in mentoring/coaching is required
Green Belt or Black Belt certification is preferred. Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence preferred
Strong understanding of Medical Device and/or Pharmaceutical Regulations is required (i.e. 21 CFR Parts 820, 210, 211, 600, 601, 610, 1270, 1271, ISO 13485, ICH Quality (Q1-Q12) )
Must have excellent communication skills. Ability to communicate clearly and concisely across all levels of the organization and across Global Supply Chain is required
Ability to foster an effective multi-functional, cross region, cross company team environment is required
Ability to forge strong collaboration and teaming with suppliers and internal stakeholders
50-70 % domestic and international travelQuality (Eng)

Staff Supplier Quality Engineer Resume Examples & Samples

Maintains, enforces, and measures supplier quality processes, including Aggregate Failure/Quality Tracking by commodity
Maintains the Quality System and its subparts as related to Supplier Quality
Provides topical knowledge in applicable domestic and international regulations and standards e.g., QSR, MDD, 13485 and CMDCAS
Minimum of 10%-15% travel
Commodity Specific Technical Expertise (PCBA, Wire Harnesses, Machining, Sheet Metal, Molded Plastics, and OEM)
Supplier / Project Management Experience
Demonstrated Collaboration, Negotiation & Conflict Resolution Skills
Supplier Audit and or Lead Assessor Experience
Knowledge of Quality System Standards QSR, ISO3485 and ISO9001

Staff Supplier Quality Engineer Resume Examples & Samples

Drive supplier quality and productivity improvement
Conduct onsite supplier quality assessments and drive closure of findings
Implement TE supplier quality strategies, procedures and initiatives
Monitor and track supplier APQP activity through PPAP
Lead manufacturability reviews with the suppliers and present VOS to TE project teams
Facilitate rapid resolution of critical supplier quality issues
Organize containment activities and/or production monitoring on a need-to-support basis
Ensure timely implementation of permanent corrective actions and resolution
Enforce supplier compliance to TE supplier quality manual
Audit skills with TS and/or ISO system background
Ability to train and lead: APQP, FMEA’s, Control Plan, Run at Rate, PPAP
Strong team player with ability to work effectively on cross-functional teams
Ability to travel as required. Estimated 30% - 60%
Certified problem solver: 8-D, Red-X, Six Sigma Green Belt a plus
Excellent communication skills; both verbal and written
Bachelor’s Degree in Business or Technical discipline; or equivalent experience
Minimum 3 years SQE experience in manufacturing quality (automotive a plus)
Demonstrated self-starter and able to work independently to execute strategies and meet goals
Experience with the following materials and processes is preferred

Senior Staff Supplier Quality Engineer Resume Examples & Samples

Degree Holder from a recognized university with 4 years experience preferred
Working experience as Process/ Supplier/ Customer Quality will be an added advantage
Knowledge on ISO 9001/ CCC/ ROSH/ UL
Able to communicate and write in English and Mandarin
Knowledge of 8D methodology and other QC tools e.g. SPC, 5S , Kaizen etc

Staff Supplier Quality Engineer Resume Examples & Samples

Supervision of Technicians
Changing the way we do business – continuously improving our policies and procedures
Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities
A minimum of a Bachelor's degree is required. A degree in Engineering, Life Science, Physical Science or a related field is preferred. An advanced degree is also preferred
A minimum of 6 years Quality experience or related experience is required
Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is preferred
An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset. Prior project management experience is preferred
Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred
It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc
This position is located in Cincinnati, OH and may require up to 25% of both international and domestic travel

Staff Supplier Quality Engineer Resume Examples & Samples

Component development as part of New Product or Process Introduction
Selection of suppliers for highly engineered components
Implementation of Critical to Quality requirements for externally manufactured components ensuring robust processes at suppliers that meet CTQ’s
Qualification of highly engineered components including validation, requirements review, risk management such as FMEA’s and Control plans, Test Method validation and measurement system analysis, Development of inspection strategies
Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements
Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis)
Leading or contributing to the reliability assessments of product design
Leading and/or contributing to root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions
Conducting and supporting the development of, test methods in equipment, process, and product qualifications/validations
Developing, implementing, and/or maintaining process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed
Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics). Perform or guide Measurement Systems Analysis (MSA)
Mentoring others in various technical capabilities
Interpreting standard and non-standard sampling plans
Participating in technical reviews as appropriate
Supporting execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies
Design control
Good documentation practices
Good manufacturing practices
Organizational requirements
Root cause analysis and Corrective Action / Preventive Action (CAPA) expectations -

Staff Supplier Quality Engineer Resume Examples & Samples

Self-manage required supplier audits from scheduling through to closure of the audit
Core team member of new product development focused on required activities for set up of new suppliers / oversight of supplier validations / transfer of processes to suppliers
Identify and manage supplier corrective actions and follow-up to assure completion and effectiveness
Support various quality management system improvement projects
Proactively develop and maintain broad knowledge and current technologies in the applicable functional quality system discipline(s)
Participate as a team member with other Edwards’ associates and facilities to assure a consistent application of the assigned Quality System element(s)
Bachelor Degree in engineering required
Candidates with at least 5 years’ experience in medical devices are highly preferred
Knowledge and understanding of FDA and international regulatory standards for medical devices is highly preferred
This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills are required
Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required
Certified Lead Auditor / ASQ Certified Biomedical Auditor preferred
Domestic and international travel is required. Expected 25% travel

Staff Supplier Quality Engineer Resume Examples & Samples

Lead the planning and execution of new supplier material qualification
Represent Supplier Quality Engineering on New Product Development teams & provide guidance on the appropriate selection of suppliers
Perform supplier audits on potential and current suppliers
Visit suppliers to resolve product performance & development timing concerns
Develop supplier material control plans and incoming material inspection plans
Serve as a leader within the Supplier Quality Engineering Organization, providing guidance to other team members as necessary
Bachelor's degree in an engineering field with 9+ years experience
OR Master's degree in field with 7+ years experience
OR Doctoral degree in field with 4+ years experience
Expertise in ISO 9001 based quality systems
Experience working with ERP systems such as Oracle
Strong leadership abilities. Experience with direct supervision is a plus
Proficient in the use of Minitab
Understanding and experience with performance and evaluation of process capability studies
Project management capabilities

Staff Supplier Quality Engineer Resume Examples & Samples

Utilize Quality Engineering tools for the effective and efficient development and maintenance of raw material suppliers
Utilize quality engineering principles and problem solving skills to develop and optimize supplier performance that are aligned with the overall Quality and Business vision
Ensure effective risk management to prevent unanticipated failure modes and ensure capability
Partner with Engineering, Procurement and Suppliers to ensure the application of process validation, process control, and process risk management
Partner with Engineering, Procurement and Suppliers in the investigation/correction of process failures
Implement and monitor process capability for continuous improvement at supplier end
Ensure effective supplier initiated base business change control
Proactively communicate with DQE any base business changes in design or changes in process that could affect product design
Develop systems to ensure quality of purchased raw materials and finished foods
Ensure supplier performance is monitored, reviewed and addressed as needed. Provide leading metrics to site as per applicable forums
Utilize technical skills specific to assigned commodities (Packaging & Chemicals Categories to ensure adequate quality and control plans based on critical to quality requirements
Partners in new supplier selection with Procurement & In-Direct Source partners
Participate with the Procurement in the supplier business review meetings held with the supplier
Analyzes quality data and identifies trends impacting risk benefits requirements of product and quality systems for external suppliers. Leads discussions to drive resolution
Provides recommendations or proposed changes to components based on data analysis using Process Excellence tools
Ability to effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management lifecycle
Serves as an auditee for supplier audits based on yearly audit schedule. May serve as lead auditor for supplier audit and technical assessment. Effectively evaluates suppliers against applicable regulations
Prepares Quality Agreements and drives discussion with supplier while consulting SQ Management
Assist in the maintenance of the supplier quality relationship(follow-up of corrective actions, coding for metrics, etc.)
Leads component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
Ensures compliance with company policies and procedures such as Design Control, Process Validation, Test
Method Validation, Sampling Plans Development and Review, and Supplier Management and Certification
Update site on supplier quality metrics and performance at the Local Management Review of the Quality System and the Management Review Board. Compiles and recommends data driven conclusions for Management Revie
Update site on Supplier Quality Metrics on Monthly basis during monthly QDAR , Customer Service , PSLT meetings
Develop, write and approve as required policies, procedures, test methods, specifications
Serves as SME for Purchasing Controls procedures and champions the management of changes to MD Standards within Ethicon. Supports and lead activities in support of the MDD Supplier Quality Program to achieve established goals and objectives
Proactively communicate with Procurement Management, and local engineering relative to any changes in design, material, or process by assigned suppliers that could affect product design
Responds proactively to changing regulatory and business needs
To handle/lead product recall initiated because of supplier issues
Experience working in an FDA regulatory environment is preferred
This position will require relevant experience working in a manufacturing/operations environment
Knowledge of product/process Risk Management (FDA and ISO standards) is required
Experience with implementation of risk mitigation is preferred
Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc
Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired
Good technical understanding of manufacturing equipment and processes is required
Process Validation expertise is preferred
A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Demonstrated knowledge and application of QSR, MDD 93/42/EEC, ISO9001, ISO13485,14971 and other international standards
Demonstrated project management and project leadership abilities are preferred
Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project)
Effective written and oral skills
This position may require travel and will be based in a supplier location and/or Ethicon Facility.Quality (Eng)

Staff Supplier Quality Engineer Resume Examples & Samples

Provide strategic direction and systems of execution for Quality-related elements of supplier management activities, inclusive of; incoming inspection processes, supplier qualification, supplier monitoring, etc
Planning, co-ordination and execution of supplier audit program based on appropriate risk analysis, managing corrective action activities related to both initial qualification and on-going improvement of suppliers' quality execution capabilities
Support development and automation of supplier quality metrics which drive supplier improvement through targeted KPI performance
Support product introduction and transfer activities, including part-qualification with suppliers
Support sites on part problem resolution through all phases of product realization
Participates in customer-facing supplier quality activities
Support and develop site, regional & global Quality Management System elements related to supplier management to meet requirements across all key business sectors, Defense/Security/Aerospace, Healthcare/Life Sciences, etc
Support Sourcing/Materials on alternative supplier selection
Mentor and support site personnel on supplier quality activities and process effectiveness
Minimal travel may be required to meet the needs of the business (estimated 20-30%)
A minimum of a Bachelor’s degree or equivalent experience is required for this position; a Bachelor’s degree in Engineering or a similar field is highly preferred
Experience of 5 years is required for this position, assuming education requirements are met
ASQ Certification preferred (CQE, CQA, CMQOE)
Broad understanding of materials, manufacturing technologies and processes
Advanced decision making and problem solving skills required
Advanced industry/manufacturing knowledge is preferred
Advanced statistical analysis knowledge is preferred

Staff Supplier Quality Engineer Resume Examples & Samples

Support external suppliers through managing the qualification of supplier products and processes, analyzing and resolving supplier quality issues
Initiate and manage projects to improve quality, yields and value received from the supply base
Develop and execute comprehensive quality strategies for design development, verification and validation
Partner with Procurement, GTO, R&D, QRC and other departments to ensure products are efficiently and effectively transferred and integrated into steady state manufacturing
Participate in evaluation and selection of potential suppliers and external manufacturers
Support/manage base-business activities
Bachelor’s degree in Engineering/Science field is required, Master’s degree is preferred
A minimum number of 6 years of equivalent experience is required
Must possess knowledge of working in Medical Device industry
Familiarity with FDA regulated environment
Knowledge of manufacturing methods (SMT, injection molding, mechanical assembly and test)
Knowledge of supplier and external Manufacturing Quality Management experience desired
Serve as the technical expert for supplier quality and assigned area of expertise, with conceptual knowledge of all functions and business areas
Drive innovation within functional area
Builds cross-functional and cross-departmental support, fostering overall group effectiveness
Ability to influence others to achieve business objectives
Ability to support/manage multiple projects simultaneously, ability to fluently change priorities based upon business needQuality (Eng)

Staff Supplier Quality Engineer Resume Examples & Samples

Implement and monitor process capability for continuous improvement
Proactively communicate any base business changes in design or changes in process that could affect product design
Ensure supplier performance is monitored, reviewed and addressed as needed
Minimum degree in Engineering or equivalent in a Life Science or Physical Science
3-5 years’ relevant work experience, preferred in Medical Device industry
Knowledge in Medical Device Packaging and Medical Device Validation is of advantage
Demonstrated knowledge in and application of QSR, ISO9001 and ISO13485
Strong influencing skills
Sense of urgency, intellectual curiosity, prudent risk-taking
Willingness to travel 30% International & Domestic is required

Senior Staff Supplier Quality Engineer Resume Examples & Samples

Function as liaison between purchasing, engineering, manufacturing and suppliers to resolve supplier issues and to provide technical support
Work with purchasing representatives to ensure Applied Technology supplier management processes comply with ISO 9001
Ensure the Applied Technology Approved Supplier List is maintained and is accurate
Monitor supplier performance and report supplier quality trend data to management
Review/audit new and existing suppliers to assess manufacturing capability and adherence to accepted quality system practices
Lead efforts in identifying, communicating, and resolving supplier problems
Request, develop and monitor supplier corrective and preventative action plans and activities as necessary
Determine cause of supplier problems and coordinate/implement effective and timely resolutions
Participate in the timely disposition of nonconforming material as it relates to supplier responsibility
Travel to supplier sites to resolve nonconforming material concerns
Perform other responsibilities within the quality function commensurate with individual skill set
Bachelors Degree in Mechanical Engineering, Electrical Engineering, or equivalent discipline
5-10 years experience in supplier quality or quality engineering
Skilled in the application of statistical methods (e.g. ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments)
Working knowledge of CAPA and associated problem solving disciplines (e.g. 8D, 5 Whys)
Quality engineering experience in automotive or military/aerospace industries is a plus
Certified Green Belt or Black Belt is a plus
Excellent interpersonal and communications skills are vital in this role
Must be a U.S. citizen with ability to obtain necessary security clearance as required by government contract

Staff Supplier Quality Engineer Resume Examples & Samples

Manage non-conformances related to supplier non-conformances
Manage Supplier Corrective Action Requests (SCARs) from initiation to closure
Oversee supplier metrics
Continually assess the Supplier Management and QA Management system and SOPs for continual improvement
Will be responsible for maintain strong relationships and managing external suppliers
Will require up to 50% domestic and international travel

Staff Supplier Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset. An advanced degree is preferred
A minimum of 6 years Quality/Manufacturing experience or related experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is preferred
Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc

Staff Supplier Quality Engineer Resume Examples & Samples

Bachelor Degree with focus in Electrical/Electronic Engineering or Materials Science
8+ years of experience in a quality role or Manufacturing Engineering supporting high volume manufacturing
Familiar with industry quality standards and reliability requirements
Deep knowledge of Quality Management Systems, Quality procedures, and application of Quality Tools (e.g. 8D, MSA, SPC, Yield Analysis, etc.)
Experience with Semiconductor manufacturing process and IC fabrication. Knowledge of device level reliability test methods and failure analysis
Demonstrate excellent communication skills (verbal, written, presentation, and negotiation) both in English and Mandarin
Excellent interpersonal skills with ability to work in highly cross-functional and geographically dispersed organizations. Must be a strong team player and very self-motivated individual
Domestic and International travel required (15%)

Staff Supplier Quality Engineer Resume Examples & Samples

Provide leadership in design in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products
Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction
Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems
Provide review and approvals for the release of new products ensuring quality requirements are met
Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking
Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers
Responsible for following and administering safety
Compliance with safety policies and procedures
Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable
Other responsibilities may be assigned and not all responsibilities listed may be assigned
Bachelor degree in engineering- mechanical, electrical, industrial, preferred or Applicable science
CQE, CRE, CQA 2– Ratings, **CBA, BB preferred
Generally requires (6-8) years related experience
Bilingual: English/ Spanish
Negotiation / influencing
Quality Assertiveness
Analytical & Creative thinking
Project Management skills in order to support multiple projects simultaneously
Problem-solving & priority setting
Organizational & integral-synthesize information from a variety of sources
Understand concepts quickly
Research and maintain ongoing learning of industry and regulations
Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market approval), and Government, trade association, industry & medical publications

Staff Supplier Quality Engineer Resume Examples & Samples

Strong background and experience in NPI Quality for instrumentation hardware and qualification
Experience in the application of production and process controls including process validation, process control plans and statistical process control
Superior communication skills, both oral and written
Ability to constructively challenge concerns and engage in transparent conversations
Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
Foster an environment that values diversity and inclusion
Proficient with Microsoft Office (Word, Excel, PowerPoint)

Staff Supplier Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's degree is required. A technical/scientific discipline is required; a degree in Engineering preferred
A minimum of 6-8 years of Quality/ Engineering work experience is required
Working experience in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
Practical experience with GMP documentation and writing skills in the FDA regulated environment is required
Broad experience with GxP Quality Systems, including but not limited to investigations, qualification/validation, CAPA, Supplier/Purchasing Controls, SQA, material/production/process controls, and supplier certification is strongly preferred
Working experience of Medical Device-associated Chemicals & Textiles and Qualifications is strongly preferred
Demonstrated practical knowledge and skills in and application of SQM, QSRs, and ISO13485 are highly desirable
Professional Certification, training, or working knowledge/skills in Project Management/FPX is strongly preferred
Professional Certifications: ASQ CQE, CSQP, CMQ/OE, CSSGB, CSSBB, and/or CQA strongly preferred
Process Excellence Certification (J&J Six-Sigma/Lean Green Belt/Black Belt) is preferred
Working knowledge of Quality Risk Management tools (e.g. ISO 14971, FMEA/FMECA/FTA/HACCP, etc.) preferred
Familiarity with material/component/process/equipment qualifications and validations is desirable
The position will be based in Cornelia, GA or Athens, GA. It will require frequent visits to the Athens, GA or Cornelia, GA facility and up to travel up to 35% internationally & domestically is required

Staff Supplier Quality Engineer Resume Examples & Samples

Act as liaison for customer groups on key compliance issues
Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes
Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review
Drive continuous improvement activities focusing on supplier quality
Bachelor’s Degree in Engineering or Science fields
Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics
Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions

Staff Supplier Quality Engineer Resume Examples & Samples

Collaborates with Procurement, R&D and Operations to effectively define roles and responsibilities and supply priorities and actions
Ensures the Supplier Quality function operates according to procedures and provides direction to other departments. Is a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
Manages the Material Review Board meetings, Supplier Review Board meetings and other critical decision-making meetings as required to define Suppliers roles, responsibilities and effectiveness

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