DQS Medizinprodukte GmbH | Germany | 61xxx Bad Vilbel | Permanent position | Full time / Home office | Published since: 09.10.2026 on stepstone.de
Lead Auditor/Product File Reviewer (m/f/d)
Required. Competent. Dynamic: So we understand the DQS medical devices, us and the services for our customers. We are pooling our expertise in the certification and notification of management systems and products for the medical industry in healthcare, health care and medical product safety. We are part of the international DQS group with around 1,000 employees, for which more than 2,500 top-qualified and experienced auditors are in use. Our core competencies are the implementation of tailored certification audits and assessments. Future-oriented topics such as sustainability, security and quality are at the focus. This means that we are one of the world's leading providers with the aim of setting new standards for reliability, quality and customer orientation with our highly qualified team at any time. Lead Auditor (all genders)
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Your tasks • Your profile • What we offer
Assessment of technical documentation (TD review) of medical devices under MDR. Performance of audits according to MDR, ISO 13485, and MDSAP, if applicable. Assessment of changes to products and QM systems, SSCPs, PSURs, and Vigilance, as part of continuous monitoring. Professional exchange with internal and external experts (e.g. clinical experts, risk assessors). Support for government requests, if necessary Participation in inspection by ZLG, DAkkS, and SCC. Final approval of medical devices
Complete studies in a relevant field (e.g. medical technology, biomedicine, engineering, natural sciences). Multiannual professional experience (> 4 years) in the development, production, testing or quality assurance of active or non-active medical devices. Mind. 5 years of professional experience as an auditor and/or product assessor at a designated body for the MDR Regulation (EU) 2017/745. Their professional experience has proven to cover a wide range of medical devices (MDA and/or MDN codes) as well as technologies (MDT codes). MDS1001, MDS1003, MDS1008 (please specify all codes in the application). Deep knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP documents, as well as other regulatory requirements, MDCG guidelines and product standards. Recognised and proven qualifications as lead auditor for MDR, ISO 13485 and ideally MDSAP. Ability to assess complex technical and clinical circumstances. Current knowledge of German and English in word and writing. readiness for international travel (as required)
A powerful and sympathetic team awaits you, a collegial, systematic training and interesting opportunities for further education. In addition, we offer you an attractive, performance-related remuneration, the opportunity to actively contribute and develop, as well as modern working conditions in an international environment. Benefits: Hybrid work: Office & Remote Flexible working hours Job ticket Jobrad 30 days off Assets
Location
 | DQS Medizinprodukte GmbH | |
| 61118 Bad Vilbel | ||
| Germany |
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