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Senior Supplier Quality Engineer

Job in Asheville, Buncombe County, North Carolina, 28814, USA
Listing for: Medtronic
Full Time position
Listed on 2026-05-23
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer, Biomedical Engineer
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 99200 USD Yearly USD 99200.00 YEAR
Job Description & How to Apply Below

We anticipate the application window for this opening will close on 28 May 2026

In this exciting role as a Senior Supplier Quality Engineer, you will be responsible for supporting the oversight of manufacturing at Medtronic strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs). You will support changes to existing supplied products and processes, and oversee nonconformances and complaint investigations performed by suppliers. The position requires 25% travel to various Contract Manufacturers and OEMs.

Work in partnership with internal Medtronic R&D, Quality, and Regulatory teams to ensure supplied products conform to finished device requirements, prevent defects, and enable Medtronic to provide customers with the highest quality, reliable products while staying in compliance with applicable industry standards, regulatory requirements, and customer requirements.

As a Senior Supplier Quality Engineer, you will work independently under limited supervision, addressing difficult challenges at a supplier level. Problem‑solving will require innovative solutions, process improvements, and project or change‑management skills.

Expenses and benefits will be consistent with Medtronic’s compensation and benefits package for employees in the United States. Salary ranges for U.S. (excluding PR) locations: $99,200.00 – $. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
Health, Dental, Vision, HSAs, FSA, Life Insurance, Long‑term disability leave, Tuition assistance, and other benefits apply to regular employees working 20+ hours per week. All regular employees are eligible for incentive plans, 401(k) plan, short‑term disability, paid time off, employee stock purchase plan, and additional benefits as applicable.

Responsibilities
  • Ensure that suppliers deliver quality parts, materials, and services.
  • Qualify suppliers according to company standards and administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitor parts from acquisition through the manufacturing cycle and resolve supplier‑related problems as they occur.
  • Evaluate suppliers’ internal functions to assess their overall performance and provide feedback.
  • Provide Pre‑Market Quality Engineering support to NPD, working with Component Engineering and Post‑Market Supplier Quality Teams, to prevent defects and deliver high‑quality parts.
  • Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts, implementing strategies for driving product quality and continuous improvement.
  • Collaborate with Component Engineers to develop Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier‑Owned Quality deployment, and Control Plans for new products.
  • Define Receiving Inspection requirements and validate test methods for all internal Medtronic Test Methods.
  • Develop and prioritize an auditing schedule to ensure designated suppliers are audited regularly to meet GMP and quality standards.
Must Have:

Minimum Requirements
  • Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality; OR advanced degree in Engineering, Science or technical field with 2 years of work experience; OR PhD with 0 years relevant experience.
Nice to Have
  • Experience supporting supplier change management in the medical device industry, including familiarity with Medtronic Supplier Change Request (SCR) processes and regulated change management systems.
  • Strong knowledge of regulatory and quality requirements including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and ISO 14971 risk management principles.
  • Experience working with OEM suppliers, contract manufacturers, and sub‑tier suppliers in regulated environments, including supplier risk assessments, supplier audits, supplier performance monitoring, and supplier development.
  • Demonstrated experience evaluating design changes, manufacturing transfers, process validations, and supplier‑driven process changes.
  • Expertise in validation and process qualification activities including IQ,…
Position Requirements
10+ Years work experience
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