Head of Quality | Biologe (m/w/d)

Gold Standard Diagnostics

Dietzenbach, Hessen, Deutschland
Published Sep 4, 2025
Full-time
No information

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

German (Fluent)English (Fluent)

Additional

  • Not specified