ewimed GmbH | Germany | 72xxx Hechingen | Permanent position | Full time / Home office | Published since: 21.04.2026 on stepstone.de
Director Quality / QMB – Medical Technology (m/f/d)
This mission drives us: For more than 35 years, as a medical technology company with innovative solutions, entrepreneurial thinking and strong teams at eleven European locations, we have improved the quality of life of patients. Director Quality / QMB (m/w/d) – Medical Technology Do you understand quality management as a central control instrument in the company? Do you want to not only meet regulatory requirements, but also integrate them into processes and decisions in a sustainable manner and also ensure their implementation? Then, as QMB in our Hechingen headquarters, we are responsible for effective and future-oriented quality management. .
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Your tasks • Your profile • What we offer
take over and further develop the overall responsibility for the quality management system (QMS) according to DIN EN ISO 13485 and MDR. Control operational requirements of quality assurance including vigilance issues independently. Conduct Regulatory Affairs topics including the creation of technical documentation safely. Ensure regulatory compliance in the company, sustainably anchor and control audits and initiate improvement measures. as a QMB management decision to accompany and take over the professional and disciplinary leadership of the QM and QA teams.
provides a completed study in the technical, scientific or economic field and has several years of experience in quality management or regulatory affairs in medical technology. a certification for the Quality Management Officer (QMB) according to ISO 13485 and are safe in handling DIN EN ISO 13485, MDR and other relevant regulatory requirements. Experience in carrying out and supporting audits (lead auditors as well as audits by designated bodies). strategically think, structured and result-oriented work and convinces as a high-communication Sparring partner. has very good knowledge of German and English in word and writing.
adopt a key role that is effective throughout the company and actively develop the QMS. work in a flexible working time model in our brand new, generous office as well as after consultation in the Mobile Office. Enjoy generous additional services (including bAV, VwL, Edenred Shopping Card, EGYM Wellpass, free language courses etc.). assume to be received with open arms and to get a structured, detailed incorporation. You are looking forward to living team spirits in everyday life and at joint events, summer and Christmas festivals. .
Location
 | ewimed GmbH | |
| 72379 Hechingen | ||
| Germany |
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