Project Manager Design Transfer Quality Control for Diagnostics Products | Projektleiter (m/w/d) Design Transfer Qualitätskontrolle von Diagnostikprodukten in München (1644)
Brüggen Engineering GmbH
Job Summary
This critical role involves leading the Design Transfer of new or modified diagnostics products from development into routine Quality Control (QC), ensuring robust, sustainable, and GMP-compliant testing processes. The Project Manager will be responsible for comprehensive project management, including milestone planning, process development, and maintaining meticulous GMP-compliant documentation. A key focus is supporting regulatory submissions and preparing for authority audits, requiring strong analytical and problem-solving skills. The ideal candidate possesses a natural science degree (preferably PhD) and several years of experience in project management, Design Transfer, or QC within a highly regulated environment (IVDR, GxP, ISO). This position offers the chance to take on central responsibility in the quality assurance of innovative diagnostic solutions in an international setting, driving continuous process improvement and efficiency.
Required Skills
Education
Completed natural science degree (e.g., Chemistry, Biology, Biochemistry), ideally with a PhD
Experience
- Several years in Project Management, Design Transfer, or Quality Control
- Professional experience in a GMP-regulated environment
- Experience supporting regulatory submissions and authority audits
- Experience with Lab Diagnostics or analysis devices (Nice to Have)
Languages
Additional
- Unspecified travel percentage; Full-time, permanent contract.
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