Medical Device QA Engineer

Mission

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.

PROFIL

min bachelor in Engineering (ideally mechatronics), yu have 3 to 5 years of similar 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 QMS (ISO & FDA) 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.

Experience in risk management as per ISO 14971.

Fluent in English. French and/or German is a plus

EU or swiss passport holder mandatory

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