Sutter Medizintechnik GmbH | Germany | 7xxx Emmendingen | Permanent position | Full time | Published since: 02.03.2026 on stepstone.de
Project Manager QM System Medical Technology (m/f/d)
As an internationally active family-run company, we have been developing and manufacturing electrosurgical instruments for ENT, micro and neurosurgery for more than five decades: with the highest quality standards and innovative strength. Around 200 employees work in our modern, climate-neutral company headquarters on solutions that improve clinical results worldwide. To strengthen our QM department, we are looking for a project manager QM-System Medizintechnik (m/w/d). In this role, you develop processes independently, implement them in the company and move safely within the medical regulations. They like to work interdisciplinary and contribute to strong cooperation with their positive, solution-oriented way. .
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Your tasks • Your profile • What we offer
Responsibility for planning, implementation and further development of the QM system according to DIN EN ISO 13485, MDR and MDSAP Control of projects for the further development of paperless QM documentation (CAQ) and optimisation of process descriptions by graphic workflows and structured process representations Steering & Organisation of the CAPA Process incl. Accompanying measures as QM-Lotse/Project Manager Identification, evaluation and integration of new regulatory requirements in the QM environment Implementation of internal and external audits as well as supervision of public and customer audits Consultation and support of the departments in ensuring regulatory requirements and continuous improvement of the QM system Interface management and close cooperation with development, product management and regulatory affairs to ensure product compliance. Cooperation in product development projects, in particular in risk management files and technical documentation
completed technical or scientific studies or a comparable qualification or QM training such as quality managers or quality auditors Knowledge of national and international authorisations Experiences with design and process validations in particular FMEA good knowledge of relevant regulations and standards (MDSAP, Regulation (EU) 2017/745 (MDR), ISO 13485 + 14971) knowledge of German and English
Flexible working hours Occupational pension Hansefit Sports activities/courses as part of our company health management such as back school, business yoga or Nordic walking JobRad JobRoller Charging columns for e-cars Bicycle garage secured by chip access with charging for e-bikes Flat hierarchies and short decision paths A valued corporate culture Good transport, Emmendingen Train Station 15 minutes' walk A family and collegial working environment Management and production in a new, climate-neutral company headquarters with the latest equipment
Location
 | Sutter Medizintechnik GmbH | |
| 79312 Emmendingen | ||
| Germany |
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