QA R&D Manager | Biologe (m/w/d)

Gold Standard Diagnostics

Freiburg im Breisgau, Baden-Württemberg, Deutschland
Published Aug 21, 2025
Full-time
No information

Job Summary

The Gold Standard Diagnostics Freiburg GmbH, part of the Eurofins Group, is seeking a quality-conscious and scientifically astute QA R&D Manager. This full-time, initially two-year fixed-term position involves bridging Research & Development with Quality Assurance, focusing on ensuring regulatory compliance (e.g., ISO 13485, IVDR) in R&D projects. The role includes overseeing development, verification, and validation processes for molecular diagnostic products, creating and maintaining QM-relevant documentation, and conducting internal and external audits. The ideal candidate will collaborate closely with R&D, Regulatory Affairs, and Production to facilitate smooth technology transfer and continuously improve quality standards. This role offers an engaging environment focused on R&D, not routine analytics, within an international team, with opportunities for professional development and flexible working hours.

Required Skills

Education

Completed scientific degree (e.g., Biology, Biochemistry, Biotechnology); PhD preferred

Experience

  • Several years of professional experience in Quality Assurance, ideally in the IVD or medical technology industry
  • Experience with QM systems according to ISO 13485 and IVDR
  • Audit experience

Languages

German (Fluent)English (Fluent)

Additional

  • Initially a 2-year fixed-term contract