Beschreibung
I am currently recruiting for a high profile Medical Device company based in Winterthur, Switzerland. They are looking for a contract Quality Engineer for an initial 6 month contract.
The ideal candidate will have experience of the following:
- Must be fluent in German and English
- One QE must be able to speak Mandarin as well
- 21 CFR Part 820 Subpart G - Production and Process Controls
- ISO 13485 - Medical Device and Quality Systems
- Medical Device Production Part Approval Process (PPAP)
- Unique Device Identification (UDI) is a plus
- Knowledge of ISO 14971 - Medical Device (patient based) Risk Management pFMEA
- Process Validation experience in Medical Device,
- Experience with Test Method Validation(TMV)/Measurement System Analysis (MSA), Gage R&R
- Ability to correctly determine specifications from prints.
- Process Flow Maps
- Control points
- Reaction plan to prevent non-conforming product.
- pFMEA control for risks included in process flow map
- Experience with process monitoring of manufacturing process using Cpk and Ppk
If you are interested in this position please apply and I will be in contact ASAP to discuss the role and your experience in detail.