Senior Regulatory Affairs and Quality Assurance Engineer

Critères de l'offre

• Métiers :

  • Quality assurance Technician

• Expérience min :

  • 3 à 21+ ans

• Secteur :

  • Security & Police

• Compétences :

  • English
  • French
  • ISO 13485
  • ISO

• Lieux :

  • Le Vaud

• Conditions :

  • Permanent contract
  • Full Time

Critères de l'offre

• Métiers :

  • Quality assurance Technician

• Expérience min :

  • 3 à 21+ ans

• Secteur :

  • Security & Police

• Compétences :

  • English
  • French
  • ISO 13485
  • ISO

• Lieux :

  • Le Vaud

• Conditions :

  • Permanent contract
  • Full Time

L'entreprise : Michael Page

Our client is an international company specialized in medical devices.

Voir toutes les offres de Michael Page

Description du poste

• Technical documentation writing management (for Europe & the US);
• Involvement in the development and design of the company's medical devices;
• Risk management, from the early life of each device;
• Review and approval of validation and verification documents;
• Acting as Process Owner;
• Contribution to internal & external audits;
• Ensure strong collaboration with other teams, and supporting them in QA/RA trainings.

Description du profil

• Minimum 3 years of experience within the medical device industry;
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR, MDR;
• Experience with submitting technical files for Europe & the US;
• French and English are mandatory.