My client has 30 years of experience in manuufacturing in-vitro diagnostics products, and providing services to biotech and pharma companies all over the world.
To strengthen the team in Hamburg, they are searching for a QMB to be responsible for the quality management operations and compliance with the new IVDR.
The QMB position reports to the CEO and takes an active role in the development of the company processes, GMP and supporting compliance with regulatory requirements.
- Technical guidance and participation in the planning and implementation of the company-specific quality policy and quality goals,
- Constant evaluation and review of the further development of the QM system in accordance with ISO13485,
- Coordination of the development, updating and further development of the specification documentation of the QM with corresponding process and SOPs
- Coordination of measures for quality improvement,
- Monitoring of product and system-related preventive and corrective measures,
- The planning and evaluation of internal and external audits.
- Several years of quality management experience in the medical device industry,
- Profound knowledge of ISO13485 and ideally the IVDR requirements,
- Generalist experience and an ‘all-rounder’ skill set with a start-up mentality; someone who is very hands-on with a good sense for balance across compliance and reality.
For more information on this vacancy and others in the Medical Device industry, please contact Rebecca Stevens at Rebecca.Stevens@Adaptivelifescience.com