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Senior Supplier Quality Engineer
Medtronic. Support the Global Supplier Quality Supplier Change Implementation function for supplier transfers, component qualification, supplier quality controls, and product acceptance activities for medical devices .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supplier quality management, including supplier transfers, product qualification, and compliance with FDA regulations and ISO standards for medical devices. Proficient in developing and executing quality strategies, validation activities, and performance assessments throughout the product lifecycle.
Highest-signal resume keywords
Supplier Quality ManagementProduct QualificationFDA RegulationsISO StandardsASQ Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Supplier ControlsProduction Part Approval Process (PPAP)Statistical AnalysisMetrologyGD&TMeasurement UncertaintyGauge R&RQuality EngineeringValidation ActivitiesComponent Qualification Strategies
Soft Skills
Cross-Functional CollaborationProblem SolvingCommunication
Tools & Technologies
MinitabWindchillAgile PLM
Certifications & Qualifications
ASQ CertificationCQECQACSQPSix SigmaLean Green BeltLean Black Belt
Industry Keywords
Medical DevicesQuality AssuranceSupplier PerformanceDesign TransferProduct Lifecycle
About the role
Key responsibilities & impact- Support the Global Supplier Quality Supplier Change Implementation function for supplier transfers, component qualification, supplier quality controls, and product acceptance activities for medical devices
- Lead quality activities supporting supplier transfers and product lifecycle changes
- Partner with suppliers and cross-functional teams to define qualification and acceptance strategies
- Execute supplier and product validations
- Assess supplier performance and ensure compliance with applicable quality requirements throughout design transfer and manufacturing
- Define component qualification strategies, including PPAP requirements, qualification plans, control plans, and release readiness
- Execute supplier product qualification activities to ensure suppliers consistently deliver conforming products and materials
- Provide quality engineering guidance and compliance oversight for supplier activities throughout the product lifecycle
- Develop and execute product acceptance strategies, sampling plans, and associated test method validation activities at suppliers
- Evaluate supplier processes and quality systems, assess performance, and address identified risks or performance gaps
- Develop Product Acceptance Sampling strategies and coordinate ASL activities for transferred products
- Review and approve engineering changes, test methods, test equipment, and component engineering lifecycle deliverables
- Partner with suppliers and cross-functional teams on supplier transfers, process improvements, corrective actions, and quality performance
Requirements
What you’ll need- Bachelor’s degree in Engineering, Science, or a technical field with 4+ years of experience in a regulated industry OR advanced degree in Engineering, Science, or a technical field with 2+ years of experience in a regulated industry OR PhD
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment; U.S. work authorization sponsorship is not offered for roles below Principal level
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Experience with supplier controls, Approved Supplier List (ASL) processes, Production Part Approval Process (PPAP), product qualification, validation, and supplier quality activities
- Working knowledge of U.S. FDA regulations and ISO standards applicable to medical devices
- Experience with metrology, GD&T, measurement uncertainty, Gauge R&R, statistical analysis, and Minitab
- Experience with Windchill or Agile PLM systems
- ASQ certification such as CQE, CQA, or CSQP, or Six Sigma, DFSS, Lean Green Belt, or Black Belt certification
Benefits
Comp & perks- Competitive salary and flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan