E-ICR and Technical file assessor for IVD products (f/m/d)
Posted 20 days 9 hours ago by TÜV SÜD AG
Permanent
Not Specified
Other
Hamburg, Germany
Job Description
AUFGABEN
- Evaluation of technical documentation, product dossiers and test results of production batches of in-vitro diagnostic products, mostly class D products for blood grouping
- Writing technical reports and interaction with international clients
- Supporting the entire certification project through pro-active problem-solving and effective management of internal interfaces
- Collaboration in an international team for technical assessment of national and interna-tional clients
- Completed master&;s degree in a scientific field, e.g. biology, biochemistry or biotechnolo-gy (PhD is a plus)
- At least four years of professional experience in the diagnostics industry with blood grouping products (e.g. AB0, Rhesus), particularly in design and development
- Sound knowledge of immunology, molecular biology and related techniques
- Strong English language skills as well as routine handling of MS Office applications
- Enthusiasm, passion and good self-management skills