Quality Assurance Manager
vor 1 Woche
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**:
**Ref. No. 6219**:
**80 - 100%**:
**Quality Assurance Manager**:
**80 - 100%**:
**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
**Your perspective**:
With us you will find interesting job content, promising development opportunities and attractive employment conditions. We offer you the prospect of helping to shape the innovation-driven and quality-oriented world of medical technology.
**Your benefits**:
- Holidays- Work time- Mobility- KTG UVG- Pension fund- Loyalty bonus**Contact**:
**Jan von Felten**
HR Recruiting Partner- Your future place of work-
- +41 (0) 34 424 46 77**The Ypsomed Group**: The Ypsomed Group is a leading developer and manufacturer of injection and infusion systems for self-medication and a renowned diabetes specialist with over 35 years’ experience. Ypsomed has its headquarters in Burgdorf, Switzerland, and operates a global network of manufacturing sites, subsidiaries and distributors. The Ypsomed Group employs around 1900 employees.
**Company presentation**:
- Ypsomed is a leading developer and manufacturer of injection and infusion systems for self-medication and a renowned diabetes specialist.**Further information**:
- Our Company
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