E-ICR and Technical file assessor for IVD products (f/m/d)
TUV SUD
Your tasks
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
Your qualifications
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