- Handling of certification processes and conformity evaluation processes according to IVDR - Assuring the application of the QM system in the department and support maintenance of the TÜV SÜD Product Service GmbH accreditation/designation - Representing the department in front of external actors within the framework of talks, lectures and meetings with clients - Clarifying technical questions raised by project leaders, auditors, experts in the field and clients on behalf of certification managers - Maintaining the authorizations through the review of technical documentations of non-active medical devices as well as the execution of audits, including the technical reports associated with such audits - Carrying out technical evaluations and making the final decision regarding certifications and maintenance of certification - Supporting, training and monitoring of technical certifiers - Master or promotion in biology, biochemistry, biotechnology, etc. - At least 5-6 years of experience in the field of IVD - Knowledge of quality standards and accreditation models especially IVDR - Good English skills (German is a plus) - Willingness to travel (up to 10-15% of working time)
Senior technical certifier for IVD products (f/m/d) (Ingenieur/in - Medizintechnik)