Senior Supplier Quality Engineer

Medtronic • Memphis, MN

3d • Onsite

About The Position

The Senior Supplier Quality Engineer supports Medtronic’s Global Supplier Quality Supplier Change Implementation function, focusing on supplier transfers, component qualification, supplier quality controls, and product acceptance for medical devices. The role is based in Mounds View, Minnesota; North Haven, Connecticut; or Memphis, Tennessee, and requires onsite work at least four days per week. Periodic travel to supplier and Medtronic facilities is expected, at less than 25%. The engineer leads quality activities for supplier transfers and product lifecycle changes, partnering with suppliers and cross-functional teams to define qualification and acceptance strategies, execute validations, assess supplier performance, and ensure compliance with applicable quality requirements during design transfer and manufacturing.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field and 4+ years of experience in a regulated industry; or an advanced degree in Engineering, Science, or a technical field and 2+ years of experience in a regulated industry; or a PhD.
• For Baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Roles below Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• 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.

Responsibilities

• Define component qualification strategies, including Production Part Approval Process (PPAP) requirements, qualification plans, control plans, and release readiness.
• Execute supplier product qualification activities to ensure suppliers can 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 supplier test method validation activities.
• Evaluate supplier processes and quality systems, assess performance, and provide feedback to address identified risks or performance gaps.
• Develop Product Acceptance Sampling strategies and coordinate Approved Supplier List (ASL) activities for transferred products.
• Review and approve applicable 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.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and the Simple Steps global well-being program.
• For all regular employees: incentive plans; 401(k) plan with 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; and Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior