(Executive) Auditor for In-Vitro Diagnostics/IVD (m/f/d)
At the TÜV SÜD Group we live our passion for technology. Innovations affect our lives in a variety of ways. At the TÜV SÜD Group, we are highly striving to be an important part of this progress. We test, we certify, we check, we advise. For the safety of people and society, we are asking ourselves out every day. We live technology, we strive for professional excellence, we set signs. We take the future into our hands. We're the TÜV SÜD group. .
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Your tasks • Your profile • What we offer
(Real) performance of audits according to EN ISO 13485, IVDD, IVDR and MDSAP at manufacturers of In-Vitro Diagnostics (IVD) Responsible customer support of national and international in-vitro diagnostics manufacturers Ensuring transparent and reliable planning and processing of conformity assessment procedures and customer orders and requests Engaged cooperation on QM processes and independent project work at global level Continuous training in QM-relevant and regulatory issues within the organisation
Successfully completed scientific-technical or medical-technical university studies (mind. BSc), e.g. medical technology, medicine, biochemistry or biology (required incl. modules of electrical engineering) At least four years of professional experience with IVD products, e.g. in production, research & development or product releases At least two years of professional experience within a quality management system (QMS) and high competence in QMS Knowledge and experience in the methodology and functioning of IVDs such as infection diagnosis, diagnostics for self-application, NAT test systems, ELISA, immunodetection or blood group determination Knowledge and experience gained in the production and development of IVD devices including Software and IVD “stand-alone” software Enthusiasm, passion and flexibility with convincing appearance German and English language skills in word and writing Organizational and Coordination Centre Routinized handling of MS Office applications Car driver's license and enjoyment of regular service trips in Germany and abroad (travel activities about 40 to 60%)
At the TÜV SÜD Group, people from more than 100 nations work together. People with different backgrounds, skills and goals. Our strength lies in these numerous and diverse perspectives. We commit ourselves to being an inclusive and diverse employer by welcoming all people. Diversity and integration is the foundation of our company and we promote an environment where all our employees can trust that You are treated with respect - regardless of age, nationality, ethnic background, disability, gender and gender identity or sexual orientation, religion or worldview. We expect our employees to behave at any time in accordance with the Ethics Code of the TÜV SÜD Group and the company values. We firmly believe that the constant anchoring of these values will continue to contribute significantly to the success of the TÜV SÜD Group. Click here to learn more about diversity at the TÜV SÜD Group. .
Location
 | TÜV SÜD | |
| 80331 München | ||
| Germany |
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