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Senior Supplier Quality Engineer
Medtronic. Support the Global Supplier Quality Supplier Change Implementation function, focusing on 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. 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 StandardsStatistical Analysis
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)Geometric Dimensioning and Tolerancing (GD&T)Measurement UncertaintyGauge Repeatability and Reproducibility (Gauge R&R)Quality EngineeringValidation ActivitiesProduct Acceptance StrategiesStatistical AnalysisComponent Qualification Strategies
Soft Skills
Cross-Functional CollaborationProblem SolvingCommunication
Tools & Technologies
MinitabWindchillAgile Product Lifecycle Management (PLM)
Certifications & Qualifications
Certified Quality Engineer (CQE)Certified Quality Auditor (CQA)Certified Supplier Quality Professional (CSQP)Six SigmaDesign for Six Sigma (DFSS)Lean Green BeltLean Black Belt
Industry Keywords
Medical DevicesRegulated IndustryApproved Supplier List (ASL)Quality ControlsSupplier Performance Assessment
About the role
Key responsibilities & impact- Support the Global Supplier Quality Supplier Change Implementation function, focusing on 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
- Provide quality engineering guidance and compliance oversight for supplier activities throughout the product lifecycle
- Develop and execute product acceptance strategies, sampling plans, and 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 Approved Supplier List 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
- Travel periodically to supplier and Medtronic facilities, less than 25%
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
- 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. Food and Drug Administration (FDA) regulations and International Organization for Standardization (ISO) standards applicable to medical devices
- Experience with metrology, Geometric Dimensioning and Tolerancing (GD&T), measurement uncertainty, Gauge Repeatability and Reproducibility (Gauge R&R), statistical analysis, and Minitab
- Experience with Windchill or Agile Product Lifecycle Management (PLM) systems
- American Society for Quality (ASQ) certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Supplier Quality Professional (CSQP), or Six Sigma, Design for Six Sigma (DFSS), Lean Green Belt, or Black Belt certification
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Roles below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment
Benefits
Comp & perks- Competitive salary and flexible Benefits Package
- Short-term incentive through 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
- 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