Spécialiste Assurance Qualité- Vigilance (rungis) H/f

Abbott

Rungis, France
**
Iso 13485:2016 compliance knowledge
Medical device vigilance support
Capa management experience
** Abbott is seeking a Quality Assurance Specialist in Rungis, France, to support the Quality Manager in implementing quality policies and ISO 13485:2016 compliance. The ideal candidate will have a background in scientific or technical studies, along with knowledge of quality assurance processes in medical devices. **

Job Summary

  • The primary mission is to support the Quality Manager in implementing the company's Quality Policy with specific indicators and control processes.
  • The role requires ensuring all activities comply with Abbott procedures and ISO 13485:2016 standards while supporting vigilance activities.
  • Candidates must participate in internal and external audits, manage CAPAs, and assist in updating procedures in collaboration with legal and regulatory teams.

Matching Summary

Match Score: 75

** Abbott is seeking a Quality Assurance Specialist in Rungis, France, to support the Quality Manager in implementing quality policies and ISO 13485:2016 compliance. The ideal candidate will have a background in scientific or technical studies, along with knowledge of quality assurance processes in medical devices. **

Skills & Requirements

Must-have

  • ISO 13485:2016 compliance knowledge
  • Medical Device Vigilance support
  • CAPA management experience
  • Supplier evaluation skills
  • Internal audit participation

Nice-to-have

  • Multi Integrated Management System (MIMS)
  • Strong interpersonal relationship skills
  • Adaptability and reactivity
  • French and international team collaboration
  • Operational English proficiency

Key Requirements

  • Bac + 2 or Bac + 3 in scientific or technical fields
  • Knowledge of EU regulations UE2017_745 and UE2017_746
  • GDPR regulation knowledge
  • English operational level required

Work Rights

Not specified

Tailored Resume

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