BYTEC Medizintechnik GmbH | Germany | 52xxx Eschweiler | Permanent position | Full time | Published since: 30.12.2025 on stepstone.de
Head of Department Quality Management Medical Technology (m/f/d)
For over 30 years we have been developing and producing high-quality medical devices for national and international customers as BYTEC. Our special strength lies in the efficient order development and order production of complex systems with demanding technical and safety requirements – especially in the areas of surgery, diagnostics and therapy. We are looking for a full-time job at the next time
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Your tasks • Your profile • What we offer
Overall responsibility for the quality management system (QMS) according to ISO 13485 or 21CFR Part 820 Function as Quality Management Officer (QMB) to authorities, designated bodies and customers Leadership and further development of the QM team as well as subordinate teams (quality assurance, testing, regulatory affairs and process optimization) Planning, implementation and follow-up of internal and external audits Monitoring compliance with legal and regulatory requirements (MDR, FDA, etc.) Further development and digitalization of the quality management system Processing of deviations, complaints and CAPA measures Implementation of training and awareness measures on quality, compliance and regulatory issues in the company Close cooperation with the departments of development and production
Complete studies in the field of medical technology, engineering or comparable Multiannual experience in the quality management of medical technology, ideal in the field of development and series production Experience in managing a QM team or department Knowledge of standards ISO 13485, ISO 14971 and FDA regulations (21CFR Part 820) Experience in the management of a team and in the handling of audits and certifications Safe occurrence in dealing with authorities and designated bodies Analytical thinking, structured working and strong sense of responsibility Very good knowledge of German and English in word and writing
Security: An unlimited contract of employment in a future-proof market Development possibilities: regular training and individual, targeted employee development Working atmosphere: A pleasant and friendly working environment and flat hierarchies Compensation for performance: We offer an attractive, performance-oriented payment In addition: Flexible working time models for the Work(Family) Life Balance Short decision paths Duz culture among themselves Team events, summer festivals and Christmas celebrations Jubilee services Influenza protection vaccinations And of course the classic fruit basket
Location
 | BYTEC Medizintechnik GmbH | |
| 52249 Eschweiler | ||
| Germany |
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