Beschreibung
Senior Quality Engineer - ManufacturingDate: July months, with permanent option
Main Responsibilities
- Validate and qualify devices and processes
- Prepare quality-related documents to comply with the regulatory requirements of the Med-Tech industry
- Support problems and questions arising in the production or in the other areas of the organization (also internationally) and propose adequate solutions
- Investigate to highlight errors and deviations, perform root-cause analysis and implement effective corrective actions (CAPA and NCMR)
- Manage, implement and monitor corrections and corrective actions to resolve non-conformances
- Participate in internal and external audits
- Work closely with suppliers on manufacturing matters
The profile
- Master's Degree in Mechanical, Electrical or Industrial Engineering (ETH/FH or comparable education)
- 3-5 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech industry
- Very good knowledge of the Med-Tech Industry regulations (ISO / FDA / GMP)
- In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
- Experience with CAPA and non-conformance processes
- Very good written and spoken knowledge of German and/or English
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.