Quality Management Officer | Biologe (m/w/d)
Limbach Genetics eGbR - Medizinische Genetik Mainz
Job Summary
As a Quality Management Officer at Limbach Genetics, you will play a pivotal role in maintaining and advancing the laboratory's quality management system. Your daily responsibilities include ensuring compliance with international standards such as ISO 15189 and the IVDR (In Vitro Diagnostic Medical Device Regulation). You will act as the primary interface for accreditation bodies, plan and conduct internal audits, and oversee the validation documentation for new diagnostic procedures. Furthermore, you will be responsible for drafting and updating Standard Operating Procedures (SOPs) and managing the document control system. This role is ideal for a detail-oriented professional with a background in biological or medical sciences who thrives in an interdisciplinary environment. You will join a leading genetics group that values scientific rigor, empathy, and a collaborative 'hands-on' culture, offering significant opportunities for professional growth in a stable, forward-thinking organization.
Required Skills
Education
Completed degree (B.Sc., Master) in biological or medical natural sciences; alternatively, completed training as a Medical or Biological Technical Assistant (MTA/BTA) or equivalent qualification.
Experience
- Professional experience in quality management within a diagnostic or medical laboratory
- Experience in the validation of diagnostic procedures
- Experience in drafting and maintaining Standard Operating Procedures (SOPs)
- Experience with document management systems is considered an advantage
Languages
Additional
- Must be eligible to work in Germany. Proficiency in relevant accreditation guidelines (e.g., DAkkS) is required.