QA Manager Combination Product and Device
(m/f/d)
Freelance/temporary employment for a project Basel Stadt Start date: asap Reference number: 822969/1
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Responsibilities
1. For allocated Medical Device / Combination Product development projects:
2. Serve as the Quality SPOC for allocated Device Development or commercial project and ensure all projects follow the applicable design control and risk management procedures
3. Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
4. Create and deploy Risk Management Plan / Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
5. Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls
6. Represent department at Quality Review Board and Change Review Board meetings
Profile
7. BS degree in Life Sciences discipline or Chemical/mechanical engineering, Graduate degree preferred
8. Experience and hands on expertise in device quality or device development
9. Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
10. Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
11. Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
12. Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
13. Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
14. Fluent in English, German advantageous
Benefits
15. Unlimited employment contract with Hays (no Freelancing)
16. A very renowned company
17. Fascinating, innovative environment in an international atmosphere