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Medtronic

Medical device maker advancing therapies

Senior Supplier Quality Engineer

Quality EngineeringUpdated on Nov 13
Full-time

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a technical field and at least four years of experience in a regulated industry; alternatively, an advanced degree in Engineering, Science, or a technical field and at least two years of experience in a regulated industry; or a PhD.
  • 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).
  • Candidates must possess unrestricted U.S. work authorization at hire and for the duration of employment because this below-Principal-level role does not offer U.S. work authorization sponsorship.
  • The role requires working onsite at least four days per week, with periodic travel to supplier and Medtronic facilities of less than 25%.

Responsibilities

  • Define component qualification strategies, including Production Part Approval Process 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 test method validation activities at suppliers.
  • 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 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.

Desired Qualifications

  • Experience with supplier controls, Approved Supplier List processes, Production Part Approval Process, product qualification, validation, and supplier quality activities.
  • Working knowledge of U.S. Food and Drug Administration regulations and International Organization for Standardization standards applicable to medical devices.
  • Experience with metrology, Geometric Dimensioning and Tolerancing, measurement uncertainty, Gauge Repeatability and Reproducibility, statistical analysis, and Minitab.
  • Experience with Windchill or Agile Product Lifecycle Management systems.
  • American Society for Quality certification such as Certified Quality Engineer, Certified Quality Auditor, or Certified Supplier Quality Professional; or Six Sigma, 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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