Auditor Non-Active Medical Devices (m/f/d)

Reference code: 19639 Company: TÜV Rheinland LGA Products GmbH

We share the enthusiasm for forward-looking solutions with over 28,000 people around the globe. At TÜV Rheinland you can contribute your knowledge independently and continue to develop in person. We are a team of highly qualified experts who face responsible challenges to enrich life with valuable achievements. And we all love what we do. If you want to bring your talents in a meaningful way, you will come to TÜV Rheinland. Let us take advantage of these diverse possibilities and make ourselves together on new goals. As an auditorin for non-active medical devices, you audit medical device manufacturers on the basis of EU Regulation 2017/745 and EN ISO 13485 standards and EN ISO 9001 and other international regulations, such as MDSAP or TCP. You conduct unannounced audits according to MDR (EU) 2017/745 at manufacturers. You evaluate product documentation in the field of non-active medical devices based on EU Regulation 2017/745. In your position as an auditorin you are competent contact for our customers from the medical device industry. You provide timely reports and documentation on customer projects. A comprehensive integration and corresponding further training is of course for us. We support you with the authorization to the auditorin/lead auditorin/product specialists and promote your professional training and further development in your product expert.

A degree in a medical, medical or scientific (special) university course in relevant courses, such as medicine, pharmaceutical, engineering or other relevant sciences At least 4 years of professional experience. Of which at least 2 years in the field of development, production or quality assurance, quality management or regulatory affairs of non-active medical devices Prove knowledge of selected medical device groups (e.g. material products, non-active functional implants or non-active soft tissue implants, dental implants, ophthalmic products etc.) and ideally completed auditor training Handling the relevant EU regulation and the applicable standards for quality management systems and medical devices German language skills (C1) and very good English skills (B2) in word and writing Class B driving licence for the exercise of indoor and outdoor services we require

Training offers - from coaching and mentoring programs to the 'Women ́s Network'. Employee talks - Regular exchange at eye level. Well insured - accident insurance, occupational disability insurance, discounted insurance. Health protection measures - occupational sports groups, seminars, precautionary measures and more. Benefits - discounts for employees, e.g. in the sports studio or when buying a car. .