STRATEC SE | Germany | 75xxx Birkenfeld | Permanent position | Full time | Published since: 08.04.2026 on stepstone.de
Specialist Quality Management & Digital Compliance (m/f/d)
STRATEC develops and produces fully automatic analysis systems for leading partners in in vitro diagnostics and life science. From concept to finished product - we make everything in-house and count on the comprehensive know-how of our employees.
Looking for a new challenge with social added value?
Then become part of our team in Birkenfeld
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Your tasks • Your profile • What we offer
STRATEC develops and produces fully automatic analysis systems for leading partners in in vitro diagnostics and life science. From concept to finished product - we make everything in-house and count on the comprehensive know-how of our employees.
Looking for a new challenge with social added value?
Then become part of our team in Birkenfeld
DISCLOSURE You take the strategic lead in the further development of the DMS and training tools in close cooperation with IT as well as the strategic support of key users at the STRATEC Group sites You control, evaluate and validate new releases of these two software tools to ensure complete compliance status You carry out the professional advice of executives and process owners in document management in the systems You coordinate regular exchange with the key users for optimal use of the DMS and training software You directly support the Corporate VP Quality Management & Regulatory Affairs with higher quality and document management topics
DEIN PROFIL
You have completed vocational training with experience in the regulated environment (medical technology, IVD or pharmaceutical) You have very good knowledge of EN ISO 13485, FDA GMP and the IVD Regulation You have experience in the establishment and validation of DMS and training software tools You have very good English skills in word and writing as well as experience in working in interdisciplinary teams You are characterized by strategic thinking, proactivity and an independent, solution-oriented way of working out
DEIN PROFIL You have completed vocational training with experience in the regulated environment (medical technology, IVD or pharmaceutical) You have very good knowledge of EN ISO 13485, FDA GMP and the IVD Regulation You have experience in the establishment and validation of DMS and training software tools You have very good English skills in word and writing as well as experience in working in interdisciplinary teams You are characterized by strategic thinking, proactivity and an independent, solution-oriented way of working out
Location
 | STRATEC SE | |
| 75217 Birkenfeld | ||
| Germany |
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