Principal Supplier Quality Engineer
About The Position
The Global Supplier Quality Supplier Change Implementation Team supports supplier transfers and supplier quality activities across the product lifecycle, focusing on product quality, patient safety, and compliant supplier processes. This position is based in Mounds View, Minnesota, and requires working onsite at least four days per week. Periodic travel to supplier and Medtronic facilities is expected, less than 25%. The Principal Supplier Quality Engineer leads quality activities for supplier transfers, providing Quality Assurance Engineering expertise across design transfer, manufacturing readiness, supplier qualification, and process improvement. The role partners with suppliers and cross-functional teams to establish qualification and product acceptance strategies, execute validations, assess supplier performance, and ensure transferred products meet applicable quality and regulatory requirements.
Requirements
- Bachelor's degree in Engineering, Science, or a technical field and at least 7 years of relevant experience; or a master's degree and at least 5 years of relevant experience; or a PhD and at least 3 years of relevant experience.
- For baccalaureate degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice To Haves
- Experience with supplier controls, Production Part Approval Process (PPAP), supplier qualification, product validation, and Approved Supplier List management.
- 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), Gauge Repeatability and Reproducibility, measurement uncertainty, capability analysis, and statistical analysis using Minitab.
- Experience with Windchill or Agile Product Lifecycle Management (PLM) systems.
- American Society for Quality (ASQ) Certified Quality Engineer, Certified Quality Auditor, or Certified Supplier Quality Professional certification, and/or First Time Quality, Design for Six Sigma, Lean, Green Belt, or Black Belt certification.
Responsibilities
- Define component qualification strategies using Production Part Approval Process (PPAP) methodologies, and establish supplier qualification plans, performance measures, and release readiness criteria.
- Execute product and component qualification activities to ensure suppliers can consistently deliver conforming products and materials.
- Lead Supplier Quality activities throughout the product lifecycle and provide technical guidance on supplier quality and compliance requirements.
- Develop and execute product acceptance strategies, supplier control plans, sampling strategies, and associated test method validations.
- Review and approve Engineering Change Notices, test methods, test equipment, and other quality deliverables supporting supplier transfers and manufacturing readiness.
- Evaluate supplier processes and quality systems, identify performance gaps, and provide feedback to improve supplier performance.
- Coordinate Approved Supplier List activities and Supplier Owned Quality deployment for transferred products.
- Analyze and communicate supplier quality indicators and performance data to support cross-functional business decisions.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Global well-being program (Simple Steps)
- Incentive plans, including the Medtronic Incentive Plan (MIP) short-term incentive
- 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
- Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums
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What This Job Offers
Job Type
Full-time
Career Level
Principal
