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Medtronic

Medical device maker advancing therapies

Principal Supplier Quality Engineer

Quality EngineeringPosted on Nov 5
Full-timeMounds View, MN, USA

About the Job

Requirements

  • A 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 a Baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

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.

Desired Qualifications

  • 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.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

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