Quality Control Manager | Biologe (m/w/d)
pes Gesellschaft für medizinische Diagnosesysteme mbH
Job Summary
This role involves leading the Quality Control department for a company specializing in state-of-the-art In-vitro Diagnostics (IVD), with a current focus on immunodiagnostic assays. The manager will be responsible for coordinating the testing and subsequent compliant release of raw materials, bulk products, and finished goods, ensuring alignment with production schedules and economic efficiency. Key duties include establishing batch-specific target values for calibrators and controls, validating analytical methods, and maintaining continuous compliance with quality standards like DIN 13 485 and IVDR. The ideal candidate must possess a degree in Biochemistry or Biology, over five years of experience in Quality Control within a regulated environment, and profound knowledge of immunoassays and their calibration. This position offers a dynamic environment characterized by a flat hierarchy, rapid decision-making processes, modern laboratory facilities, and family-friendly flexible working hours.
Required Skills
Education
Degree in Biochemistry, Biology, or comparable qualification
Experience
- 5+ years in Quality Control in a regulated environment
- Professional experience in immunoassay calibration and standardization
- Professional experience coordinating testing of raw materials and finished products
- Professional experience in OOS, Change Control, and CAPA management
Languages
Additional
- Not specified