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Quality System Manager

vor 1 Monat


Solothurn, Schweiz Ypsomed Vollzeit

Our team is looking for a passionate senior quality expert and friendly colleague as

**Quality System Manager | **80 - 100%**:
Ref. No. 6394
- Location:

- Solothurn- , Burgdorf- | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

**Your main tasks**:

- Lead projects related to the management system, certifications, roll-out of processes to new international sites, expansion to new markets (e.g. US) or improvement projects
- Conduct internal audits as well as organise customer audits, notified body / certification body audits and inspections as part of the audit team. Closely support corrective actions / improvements to ensure effective implementation
- Quality Subject Matter Expert working in collaboration with process owners and related departments
- Ensure smooth and timely implementation of new and changed requirements.
- Review new and changed processes to assure compliance with applicable requirements (i.e. ISO 13485, EU-MDR, 21 CFR 820, MDSAP and others)
- Provide trainings throughout Ypsomed in the field of expertise.
- Advise Ypsomed’s business units regarding quality management system (QMS): e.g. document management, change control, training, audit management, deviation management

**Your profile**:

- Technical, medical or science education at university of applied sciences or equal
- Further training in the field of quality management of medical devices / GMP
- Several years of relevant practical experience in life science industry with proven success stories
- Project management / change management experience
- Proficient use of quality management software (e.g. TrackWise, SAP, etc.)
- High quality awareness
- Self-reliant and output-oriented work style
- Good English (C1) and German (B2) language competence