One of our Medical Device clients is looking for a Design Quality Engineer (software focus) for a 6-month project in the German-speaking part of Switzerland. It is a Hybrid role.
- Review and approval of documents and change requests
- Working with cross-functional teams to define design requirements
- Participation in project planning (new development, product update, product maintenance / technical changes)
- Extensive knowledge of 21CFR Part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, ISO 14971, IEC 62304, ISO 62366, ISO 80601-2
- Several years of experience with international standards and official regulations for medical devices, preferably in the areas of hardware, software integrated and stand-alone, consumables and exercising them
- Fluent German and English knowledge
*Please note, only those with the right to work in Switzerland can apply!