Quality Engineer

Medtronic UK

Netherlands
Base: 55,200.00 eur - 82,800.00 eur; bonus/equity:...
Fda and international regulatory requirements
Iso 13485 and mdsap knowledge
Root cause analysis and capa execution
This role involves leading quality system support to maintain compliance with FDA and international regulatory requirements for medical devices

Job Summary

  • This role involves leading quality system support to maintain compliance with FDA and international regulatory requirements for medical devices.
  • The position requires owning nonconformity investigations, performing root cause analysis, and driving corrective and preventive actions to resolve compliance issues.
  • Medtronic offers a competitive salary range of 55,200.00 EUR to 82,800.00 EUR along with flexible benefits and a short-term incentive plan.

Matching Summary

This role involves leading quality system support to maintain compliance with FDA and international regulatory requirements for medical devices.

Salary

Base: 55,200.00 EUR - 82,800.00 EUR; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Competitive flexible benefits package

Skills & Requirements

Must-have

  • FDA and international regulatory requirements
  • ISO 13485 and MDSAP knowledge
  • Root cause analysis and CAPA execution
  • Internal and external audit preparation
  • Medical device manufacturing processes

Nice-to-have

  • Proactive quality oversight support
  • Strong written and oral communication
  • Ability to manage multiple critical projects
  • Experience with EU OU Surgical entities
  • Data analysis and trend identification skills

Key Requirements

  • Bachelor's degree with 4 years experience or advanced degree with 2 years
  • Demonstrated knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP
  • 2+ years experience in Medical Device Manufacturing setting
  • Experience supporting regulatory inspections and audits

Work Rights

Not specified

Tailored Resume

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