Head of Quality | Biologe (m/w/d)
Gold Standard Diagnostics
Job Summary
This pivotal role involves leading and advancing the Quality Management and Quality Assurance (QM/QA) department for a global in vitro diagnostics (IVD) developer and manufacturer. The successful candidate will be responsible for ensuring all processes adhere to current standards, regulatory requirements, and internal protocols, with a strong focus on continuous improvement of the QM system in line with ISO 13485, IVDR, and potentially FDA requirements. Day-to-day tasks include managing audits, certifications, and authority inspections, optimizing quality processes like CAPA and change control, and fostering a strong quality culture within the organization. This position offers the opportunity to actively contribute to the development of a strategically important site within an international, future-oriented company, supported by an attractive compensation package and opportunities for professional growth.
Required Skills
Education
University degree in Natural Sciences, Quality Management, or comparable qualification
Experience
- Professional experience in Quality Management, ideally in diagnostics or medical technology
- Leadership experience
Languages
Additional
- Not specified
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