Quality Assurance Manager - IVD / Life Science | Biologe (m/w/d)

Zytomics

Bremerhaven, Bremen, Deutschland
Published Oct 23, 2025
Full-time
No information

Job Summary

This role is a central Quality Assurance Manager position within the IVD (In-vitro Diagnostics) and Life Science sector, based in Bremerhaven. The primary focus is ensuring exceptional product quality and strict adherence to regulatory requirements, thereby contributing significantly to the company's mission in clinical cancer diagnostics. Daily responsibilities include coordinating activities to maintain an IVDR/DIN ISO compliant Quality Management System (QMS), generating and updating critical internal documentation such as process descriptions and work instructions, and meticulously tracking complaints, deviations, and CAPAs. The successful candidate will also prepare, conduct, and follow up on internal audits, and drive continuous process optimization across departments. Key requirements include a completed scientific degree (e.g., Biotechnology, Biology, or Chemistry), and a minimum of two years of professional experience in Quality Management. This is an 18-month fixed-term contract with potential for extension, offering a challenging, future-oriented role in a growing international company dedicated to global health.

Required Skills

Education

Completed scientific degree (e.g., Biotechnology, Biology, or Chemistry)

Experience

  • At least 2 years in Quality Management
  • Professional experience in the IVD environment (ideal)
  • Knowledge in implementing DIN ISO 9001 and DIN ISO 13485 standards
  • Competence in implementing EU Regulation 2017/746 (advantageous)
  • Experience in the production of immunohistochemical IVDs (advantageous)

Languages

German (Fluent)English (Fluent)

Additional

  • Fixed-term position for 18 months (with option for extension)