Quality Assurance Manager

vor 2 Wochen

Solothurn, Schweiz Ypsomed Vollzeit

In the Quality Management, Regulatory & Medical Affairs area in the Quality Assurance department, we are looking for a customer-oriented and quality-conscious personality in the Production Management Team at the Solothurn site as a

**Quality Assurance Manager **| 80 - 100%**:
Ref. No. 6219
- Location:

- Solothurn- | 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**:

- Ensure a common standard within Ypsomed with regard to quality and regulatory requirements.
- Reviews/approves technical documentation constituents
- Provides necessary guidance and support to meet design control requirements
- Ensures outstanding inspection readiness for systems in the portfolio

**Your profile**:

- A minimum of a Bachelor’s or equivalent degree is required. Focused degree in Computer Science, Information Systems, Business Administration or other related field is preferred
- ITIL, Agile, and/or Scrum Master certifications are a plus
- At least 4 years of dynamic experience in the pharmaceutical/medical device/biotech or other regulated industry is required
- Knowledge of Software as Medical Device (SaMD) is desired, including ISO 13485, IEC 62304, IEC 82304, ISO 14971
- Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is mandatory

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