Quality Engineering Manager

Medtronic UK

Base: $150,000 to $211,200 py; bonus/equity: incen...
Not specified (assumed to be office-based or hybrid due to the nature of the role)
Gmp and 21 cfr part 820 qsr experience
Iso 13485 and eu mdr compliance knowledge
Risk assessments pha and pfmea expertise
Medtronic UK is seeking a Quality Engineering Manager to lead a team in ensuring compliance with regulatory standards and quality expectations for medical devices, particularly within the Cardiac Surgery Business Unit. The ideal candidate will possess a strong background in quality engineering, including experience with quality systems, risk management, and statistical analysis tools

Job Summary

  • Lead the quality engineering team to ensure products and processes meet regulatory standards and Medtronic's quality expectations.
  • Oversee the development and maintenance of quality systems in accordance with GMP, ISO 13485, and EU MDR requirements.
  • Enjoy comprehensive benefits including health insurance, 401(k) matching, tuition assistance, and employee stock purchase plans.

Matching Summary

Match Score: 85

Medtronic UK is seeking a Quality Engineering Manager to lead a team in ensuring compliance with regulatory standards and quality expectations for medical devices, particularly within the Cardiac Surgery Business Unit. The ideal candidate will possess a strong background in quality engineering, including experience with quality systems, risk management, and statistical analysis tools.

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 experience
  • ISO 13485 and EU MDR compliance knowledge
  • Risk assessments PHA and PFMEA expertise
  • DMAIC RCA and root cause analysis skills
  • DOE statistical analysis and process capability
  • V&V protocols IQ OQ PQ implementation
  • Minitab and Power BI analytical tools

Nice-to-have

  • First Time Quality Level 1 certification coaching
  • Strategic guidance for FTQ initiatives
  • Collaboration with engineering and manufacturing
  • Mentoring team members on performance feedback
  • Experience in Cardiac Surgery Business Unit

Key Requirements

  • Bachelor's degree in Engineering or related field
  • Five years experience as Quality Engineer in medical device industry
  • Three years experience with GMP and 21 CFR Part 820 QSR
  • Three years experience with Risk Assessments and CAPA
  • Three years experience with DMAIC and DOE methods
  • Three years experience with V&V protocols and IQ/OQ/PQ
  • Three years experience with Cardiac surgery devices

Work Rights

Not specified

Tailored Resume

Cover Letter