021 310 07 07 rh@crit.ch
  • Poste fixe
  • Lausanne

Our client, an Innovative Tech company, is currently looking for an Medtech Quality Assurance Expert (Vaud / Fixed position)

 

Responsabilities :

  • In charge of the product design Change Request process.
  • Lead the operational quality activities: Products release and Non-Conformity management.
  • Develop product expertise within the QA department to support the V&V activities linked to sterilization, packaging, and biocompatibility.
  • Monitor compliance to procedures, perform internal audits and update the Quality Management System

 

Profile :

 

  • 3 to 5 years of similar QA experience in a Medical Device company developing, manufacturing, and marketing technically complex equipment that includes mechanics, electronics, and embedded software.
  • Significant knowledge of medical devices Quality Management System (ISO-13485, 21CFR part 820) and regulatory landscape (MDD, MDR).
  • Proven experience in leading a QA processes, preferably change control and NC/CAPA handling.
  • Significant experience in single use and reusable products validation with a deep understanding of ISO 10993-x, ISO 11135, ISO 17665-1, etc.
  • Strong ability to assess rationales for impact changes.
  • Experience in risk management as per ISO 14971.
  • Degree in Engineering.
  • Fluent in English.

 

 

Expert Assurance Qualité Dispositifs Médicaux

Pour postuler, envoyez votre CV et votre lettre de motivation par e-mail à lausanne@crit.ch