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