Beschreibung
We are looking for a
Medical Device Quality System Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in Bavaria
Branch: Pharmazeutische Industrie
Your tasks:
- Implement, consolidate and further improve BTDM quality system for medical devices and combination products in accordance with current regulatory requirements
- Manage communication and interface with external contacts
- Establish QA templates and tools including electronic QA management systems in cooperation with other functions (Design Control Documentation, Risk Management, UDI)
- Lead and support quality system improvement projects and initiatives in collaboration with other BTDM departments/stakeholders
Your qualifications
- Profound experience in quality systems or compliance in the medical devices and combination product area
- Sound scientific quality system knowledge of international cGMP of medical device and combination product regulations, standards and guidelines
- Ability to influence people, negotiate and communicate
- Fluency in English in speaking and writing
Skills:
- Quality manager
Keywords: Qualitätsmanager