Project Manager Design Transfer Quality Control for Diagnostic Products | Projektleiter (m/w/d) Design Transfer Qualitätskontrolle von Diagnostikprodukten (1644)
Brüggen Engineering GmbH
Job Summary
As a Project Manager for Design Transfer in Quality Control, you will play a pivotal role in transitioning new or modified diagnostic products from the development phase into routine testing. Operating within a highly regulated GMP environment, your daily responsibilities will involve managing project milestones, establishing robust QC processes, and ensuring all documentation meets strict regulatory standards such as IVDR and ISO. You will lead interdisciplinary teams in a matrix structure, coordinating with global interfaces to ensure timely product releases. This position is particularly attractive for scientific professionals who enjoy bridging the gap between technical development and operational excellence, offering the chance to drive 'Go-Lean' initiatives and process optimizations that directly impact patient safety and diagnostic efficiency.
Required Skills
Education
Completed university degree in natural sciences (e.g., Chemistry, Biology, Biochemistry); a PhD is considered ideal.
Experience
- Several years of professional experience in project management, design transfer, or quality control within a GMP-regulated environment
- Proven experience in establishing robust QC processes and managing project lifecycles
- Experience in creating and maintaining GMP-compliant documentation and reports
- Experience in matrix leadership and coordinating interdisciplinary, international project teams
- Experience with regulatory submissions and preparation for authority audits
Languages
Additional
- The role requires a secure handling of SAP and standard Office tools. Candidates must be able to work in a highly regulated environment involving IVDR and GxP standards.
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