Quality Manager | Biologe (m/w/d)
pes Gesellschaft für medizinische Diagnosesysteme mbH
Job Summary
This role is vital for ensuring the company's state-of-the-art in-vitro diagnostics (IVD) meet stringent regulatory standards. The Quality Manager will be responsible for the continuous development and maintenance of the Quality Management (QM) system to guarantee compliance with IVDR (In-vitro Diagnostic Regulation) and DIN 13 485. Day-to-day tasks include overseeing the entire audit program, managing and updating QM documentation, and acting as the central point of contact for external bodies, customers, and suppliers regarding technical documentation and product registration. A successful candidate must possess a degree in Natural Sciences, Engineering, or Medicine, coupled with proven QM experience, ideally within the medical device or laboratory sector. This position offers the opportunity to work on cutting-edge immunodiagnostic assays within a dynamic environment characterized by flat hierarchies, rapid decision-making, modern laboratories, and family-friendly working hours (flextime).
Required Skills
Education
Successful completion of a degree (Diploma/PhD) in Natural Sciences, Engineering, or Medicine, or comparable qualification.
Experience
- Professional experience in Quality Management, preferably in the medical device or laboratory sector
- Experience in planning, organizing, conducting, and evaluating internal and supplier audits, including tracking corrective actions
- Applied knowledge of quality-related and statistical methods and procedures
- Ideally, proof of current Auditor training
Languages
Additional
- Knowledge of relevant regulatory requirements is highly desirable; Proficiency in eQMS (Electronic Quality Management System) is an advantage.