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Medtronic

Sr Quality Engineer

Medtronic

Humacao, Puerto Rico, United States of America · Senior

Listed on Medtronic’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role supports quality assurance in a regulated medical device manufacturing environment, managing investigations, compliance documentation, and continuous improvement across production processes. It suits engineers with healthcare manufacturing experience who are comfortable with FDA/ISO systems and can work cross-functionally to resolve quality issues.

Our summary, not Medtronic’s wording. The full posting is on their site.

What they ask for

Required

  • Bachelor's degree in engineering
  • Minimum 4 years of relevant engineering, quality, or manufacturing experience (or Master's degree with 2 years experience, or PhD with 0 years experience)
  • Quality systems knowledge
  • Manufacturing process experience
  • Technical documentation skills

Nice to have

  • Bachelor's or Master's degree in Mechanical, Industrial, or Electrical Engineering
  • Medical device or FDA/ISO-regulated manufacturing experience
  • Knowledge of GMP and inspection readiness
  • Validation concepts (URS, SRS, IQ, OQ, PQ)
  • NPI and product transfer support experience
  • Machining, anodizing, packaging, or inspection process knowledge
  • Structured problem-solving tools (5 Whys, Fishbone, FMEA, fault tree analysis)
  • Statistical methods and SPC capability
  • Minitab, JMP, Power BI, SAP, JDE, or Factory Works
  • Lean Six Sigma Green Belt or Black Belt
  • Automation and basic programming (VBA, Python)

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