EPM Scientific is searching for a Medical Device Quality Engineer / Manufacturing Support Consultant for a growing Medical Device company in Switzerland, this would be an initial 10 month contract which will start in January 2021.
The location of this role is in northern part of Switzerland and therefore requires fluency in German and English.
Job overview:
- NC / CAPA responsible for production related topics (incoming control deviations, production related deviation and identification)
- Creating and updating of PA for inspections / Test instruction including operator training
- Review/update of pFMEAs
- Able to identify new test equipment and methods for in process controls or incoming control (incl. measurement equipment capability analysis and support of TMV)
- Review and input for equipment qualification (new and existing)
- Review and input for process verification and validation
- Preferred would be German and English speaking fluently
- Background of medical devices (risk class II or higher) and the related standards ISO (10555, 10993) and related FDA Guidelines as well as MDR changes