Project Manager Design Transfer Quality Control of Diagnostics Products | Projektleiter (m/w/d) Design Transfer Qualitätskontrolle von Diagnostikprodukten in München (1644)
Brüggen Engineering GmbH
Job Summary
This Project Manager role is critical for ensuring the successful transfer of new or modified diagnostics products from development into routine Quality Control (QC) in a highly regulated environment. Day-to-day responsibilities include leading the Design Transfer process, managing project timelines and milestones, and establishing robust, sustainable QC processes compliant with GMP and regulatory standards. The ideal candidate will be responsible for creating and maintaining GMP-compliant documentation, supporting regulatory submissions, and coordinating interdisciplinary project teams across global interfaces. This position requires strong analytical skills, expertise in GxP/IVDR regulations, and a natural science background, offering the opportunity to drive efficiency improvements and take on a central role in the quality assurance of innovative diagnostic solutions.
Required Skills
Education
Completed natural science degree (e.g., Chemistry, Biology, Biochemistry), ideally with a PhD
Experience
- Several years of experience in Project Management, Design Transfer, or Quality Control
- Professional experience in a GMP-regulated environment
- Experience supporting regulatory submissions and authority audits
- Experience with laboratory diagnostics or analysis devices (Nice to Have)
Languages
Additional
- Not specified
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