- Support the assigned combination product development project(s) from the Design Quality perspective. Ensure that all design development work meets applicable FDA and EU MDR requirements
- Author SOPs and Guidelines for the medical device and combination product department and harmonize design control & risk management documentation
- Collaborate with the suppliers / CMOs on the following topics: qualification audits; vendor performance issues, deviations and SCARs; review and approval of drawings, specs and test reports; Quality Agreements; process validation, equipment qualification, etc.
- Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders
- Minimum Bachelor’s degree in chemical, mechanical or bio-engineering
- At least 5 years of experience in related quality engineering field
- Broad and deep understanding of disciplined quality product development processes,
regulatory, and quality / risk management systems (ISO 13485, MDR, 21CFR820, ISO14971…)
- Highly analytical and a functional team-player
- Fluent in English and ideally German
Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to firstname.lastname@example.org.