Medical Device QA Engineer
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.
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