Ingénieur Qualité F/h

Medtronic Diabetes

Fourmies, France
Base: 43,440.00 eur - 65,160.00 eur; bonus/equity:...
4 days onsite, 1 day remote
Iso13485 mdr mdsap compliance expertise
Capa and non-conformity management
Process validation and change control leadership
Medtronic Diabetes is seeking a Quality Engineer for its facility in Fourmies, France, focusing on ensuring compliance with quality standards in the production of cardiac stimulation electrodes. The ideal candidate will have expertise in quality assurance within highly regulated industries and will be responsible for leading initiatives to maintain product quality and regulatory compliance. ###

Job Summary

  • The role involves leading quality assurance initiatives to ensure compliance with ISO13485, MDR, and MDSAP regulations at a certified medical device manufacturing site.
  • Candidates will be responsible for managing CAPA processes, supervising internal audits, and guiding multidisciplinary teams in root cause analysis using tools like 5M and 5 Whys.
  • Medtronic offers a competitive salary range of 43,440.00 EUR to 65,160.00 EUR along with flexible benefits and a short-term incentive plan.

Matching Summary

Match Score: 85

Medtronic Diabetes is seeking a Quality Engineer for its facility in Fourmies, France, focusing on ensuring compliance with quality standards in the production of cardiac stimulation electrodes. The ideal candidate will have expertise in quality assurance within highly regulated industries and will be responsible for leading initiatives to maintain product quality and regulatory compliance. ###

Salary

Base: 43,440.00 EUR - 65,160.00 EUR; Bonus/Equity: Eligible for Medtronic Incentive Plan (MIP); Benefits: Competitive flexible package including career support resources

Skills & Requirements

Must-have

  • ISO13485 MDR MDSAP compliance expertise
  • CAPA and Non-conformity management
  • Process validation and Change Control leadership
  • Audit preparation and inspection liaison
  • Statistical techniques for quality control

Nice-to-have

  • Coaching and training staff on quality standards
  • Cross-functional partnership with R&D and manufacturing
  • Continuous improvement initiative leadership
  • Strong analytical and problem-solving skills

Key Requirements

  • Engineering degree or equivalent with 4-5 years QA/QC experience
  • Fluency in French and English required
  • Experience in highly regulated industries preferred
  • Knowledge of ISO9001 and GMP/BPF standards desired

Work Rights

Not specified

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