MediPac GmbH | Germany | 53xxx Königswinter | Permanent position | Full time | Published since: 02.04.2026 on stepstone.de
Head of Quality Management (m/f/d)
MediPac® is an owner-managed company and reliable partner of the pharmaceutical and medical technology industry since 1948. At our site in Königswinter, we develop and manufacture high-quality primary packaging for medical devices with around 32 employees – certified according to ISO 9001, ISO 13485, ISO 15378 and in compliance with GMP requirements. In order to lead our quality management, we are looking for an entrepreneurial thinking leadership personality that combines technical excellence with leadership.
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Your tasks • Your profile • What we offer
Your role – More than quality management As head of QM, you will report directly to the management and take over the professional and disciplinary leadership of a team of 3-4 employees. You are officers of the top management and “responsible person according to MDR, Article 15”. - This role combines leadership, entrepreneurial thinking and regulatory responsibility. What makes this role particularly important Leadership and development of a QM team with focus on responsibility and Cooperation Central interface between production, sales, product management and management linking quality requirements with economic thinking Responsibility for projects, resources and priorities Your duties Ensuring regulatory requirements (MDR, ISO 13485, ISO 15378, GMP) Planning and implementation of audits incl. CAPA Management Further development of the QM system and process documentation Control of product authorisations and certifications worldwide Responsibility for technical documentation and clinical reviews Communication with authorities and notified bodies Validation planning and mapping of QM processes in the ERP system
Multiannual experience in quality and regulatory affairs management in the medical device environment Found knowledge of the MDR and ideally ISO 13485 Experience with audits and regulatory processes Leadership experience and strong communication skills Entrepreneurial thinking and structured working
Key position with direct connection to the management Design space in a growing company Short decision-making and close cooperation Additional benefits such as occupational pension (bAV) and occupational health insurance (bKV) Working environment in the Rhineland – between Bonn and Siebengebirge
Interest awakened? We look forward to your application in German with your earliest possible entry date and your salary presentation. Your contact is Olga Brüning, reachable at personal@medipac.de and/or 02244 92784232. MediPac® GmbH - Eduard-Rhein-Straße 1-3 - 53639 Königswinter
Contact
 | MediPac GmbH | |
| Eduard-Rhein-Str. 1-3, 53639 Königswinter | ||
| Germany | ||
| show e-mail |
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