Quality Engineering Manager

Medtronic Diabetes

Base: $150,000 to $211,200 py; bonus/equity: incen...
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21 cfr part 820 qsr compliance
Iso 13485 and eu mdr standards
Risk assessment pha pfmea
** Medtronic Diabetes is seeking a Quality Engineering Manager to lead a team focused on ensuring compliance with regulatory standards and promoting continuous improvement in the quality of medical devices. The ideal candidate will have extensive experience in quality engineering within the medical device industry and will be responsible for overseeing quality systems, mentoring engineers, and driving quality initiatives. **

Job Summary

  • This role leads the quality engineering team to ensure medical devices meet strict regulatory standards including GMP, ISO 13485, and EU MDR.
  • The manager is responsible for overseeing product lifecycle management, leading investigations into non-conformances, and driving corrective actions within the Cardiac Surgery Business Unit.
  • Candidates will receive comprehensive benefits including health insurance, 401(k) matching, tuition assistance, and an employee stock purchase plan.

Matching Summary

Match Score: 75

** Medtronic Diabetes is seeking a Quality Engineering Manager to lead a team focused on ensuring compliance with regulatory standards and promoting continuous improvement in the quality of medical devices. The ideal candidate will have extensive experience in quality engineering within the medical device industry and will be responsible for overseeing quality systems, mentoring engineers, and driving quality initiatives. **

Salary

Base: $150,000 to $211,200 per year; Bonus/Equity: Incentive plans available; Benefits: Health, Dental, Vision, 401(k) match, Tuition assistance

Skills & Requirements

Must-have

  • 21 CFR Part 820 QSR compliance
  • ISO 13485 and EU MDR standards
  • Risk assessment PHA PFMEA
  • DMAIC RCA root cause analysis
  • Design of Experiments DOE statistical tools
  • IQ OQ PQ validation protocols
  • Cardiac surgery device experience

Nice-to-have

  • Minitab and Power BI proficiency
  • First Time Quality Level 1 certification coaching
  • Strategic guidance for Level 2 Coach certification
  • Enterprise-wide FTQ initiative contribution
  • Data-driven decision-making culture

Key Requirements

  • Bachelor's degree in Engineering or related field
  • 5 years experience as Quality Engineer in medical device industry
  • 3 years experience with GMP and 21 CFR Part 820
  • 3 years experience with ISO 13485 and EU MDR
  • 3 years experience with Risk Assessments and PFMEA
  • 3 years experience with Non-Conformances and CAPA
  • 3 years experience with DMAIC and Root Cause Analysis
  • 3 years experience with DOE and Statistical Tools
  • 3 years experience with V&V protocols IQ/OQ/PQ
  • 3 years experience with Minitab and Power BI
  • 3 years experience with Product Lifecycle Management
  • 3 years experience with First Time Quality principles
  • 3 years experience with Cardiac surgery devices

Work Rights

Not specified

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