Quality Engineering Manager

Medtronic

Base: $150,000 to $211,200 py; bonus/equity: incen...
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Gmp and 21 cfr part 820 qsr compliance
Iso 13485 and eu mdr regulatory knowledge
Risk assessment pha and pfmea expertise
** Medtronic is seeking a Quality Engineering Manager to lead a team focused on ensuring compliance with quality standards in medical devices, particularly within the Cardiac Surgery Business Unit. The ideal candidate will have extensive experience with quality management systems and regulatory compliance in the medical device industry. **

Job Summary

  • Lead the quality engineering team to ensure products meet Medtronic's quality expectations and regulatory standards.
  • Oversee the development of quality systems in accordance with GMP, ISO 13485, and EU MDR while managing risk assessments and CAPA processes.
  • Employees are eligible for comprehensive benefits including health insurance, 401(k) matching, and tuition assistance.

Matching Summary

Match Score: 75

** Medtronic is seeking a Quality Engineering Manager to lead a team focused on ensuring compliance with quality standards in medical devices, particularly within the Cardiac Surgery Business Unit. The ideal candidate will have extensive experience with quality management systems and regulatory compliance in the medical device industry. **

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

  • GMP and 21 CFR Part 820 QSR compliance
  • ISO 13485 and EU MDR regulatory knowledge
  • Risk assessment PHA and PFMEA expertise
  • CAPA and non-conformance investigation
  • DMAIC, RCA, and root cause analysis
  • DOE and statistical tools Cpk ANOVA Gage R&R
  • IQ OQ PQ validation protocols

Nice-to-have

  • Mentoring for First Time Quality certification
  • Strategic guidance for Level 1 and 2 Coach
  • Power BI data-driven decision making
  • Collaboration with Cardiac Surgery Business Unit
  • Experience with medical device components

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 PHA PFMEA
  • 3 years experience with Non-Conformances and CAPA
  • 3 years experience with DMAIC RCA and DOE
  • 3 years experience with IQ OQ PQ protocols
  • Knowledge of Cardiac surgery devices

Work Rights

Not specified

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