Job Description
Role
1. Interest in the development of complex (electronic, software and mechanic) medical devices
2. Defining and ensuring compliance with quality requirements for drug delivery systems and medical devices in development projects
3. Ensuring the conformity of our products and product documentation over the entire product life cycle – focus on development and industrialization – Design Control
4. Collaboration in risk analyses
5. Creation / approval of documents for design verification / design validation
6. Creation / Release of Test Plans / Test Setups / Design of Experiment
7. Review and approve changes to product design and manufacturing processes
8. Contact person for customers and suppliers regarding product quality (incl. measures such as NC, CAPA, SCAR, etc.)
9. Collaboration in the equipment qualification / process validation and evaluation of external production partners
10. Contact person for quality-related questions in the context of audits by customers or authorities
Qualifications
Profile
11. Completed technical or scientific education or equivalent
12. Several years of experience in working in the field of medical technology products, pharmaceuticals and/or in-vitro diagnostics
13. Practical experience in the risk management method for medical devices
14. Practical experience in the application of quality and problem-solving techniques
15. Knowledge in the interpretation and implementation of regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485)
16. Structured and result-oriented way of working
17. Willingness to proactively participate and make things happen, ability to prioritize and make decisions
18. Solution-oriented and communicative personality
19. Confident in communication across all hierarchical levels, internally and with customers
20. Willingness to travel (approx. 10%)
21. Very good oral and written language skills in German (B2) and English (C1)