Head of Quality Management Systems (m/f/d)

You actively contribute to the development of lean, digital processes and an internationally scalable management system. You assume overall responsibility for international authority inspections and certification audits (e.g. NMPA, FDA, MDSAP, designated bodies) and conduct complex audit programs (internal and external) with high professionalism and sovereignty. You lead the further development of our quality management system, drive eQMS and digitization initiatives and create sustainable transparency through meaningful key figures. You promptly introduce international regulatory requirements into effective processes, standards and prepare decisions to change along the entire product life cycle. You develop your team, promote cross-departmental cooperation and create an atmosphere in which quality, self-responsibility and continuous improvement are natural. As a representative of our Quality Management Officer (QMB), management and executives advise you on regulatory issues in a strategic context. You gradually take on more responsibility with the clear perspective of taking over the function of QMB and the quality management department.

You have multi-year leadership experience in the quality management of a regulated environment, ideally in the environment of active or implantable medical devices. You provide sound knowledge of relevant regulatory requirements such as ISO 13485, EU-MDR and ideally FDA QMSR, MDSAP, NMPA or comparable international regulatory requirements. You have successfully conducted complex audits or government inspections and are also subject to pressure to sovereign, binding and solution-oriented. You have several years of expertise in the further development of QMS structures as well as in transformation, reorganisation or digitization projects. You think entrepreneurial, make clear decisions and win people for changes and common goals. You communicate confidently in German and English and are confident in exchange with internal and external stakeholders and international audits.

Flexible and family-friendly working time models as well as a working environment that promotes self-responsibility, trust and reconciliation of family and profession and in which we can be ourselves. The opportunity to actively shape the future of our quality management and take responsibility in a strategically important function. Extensive possibilities for professional and personal development as well as an open corporate culture with dedicated teams and a high degree of design playroom. Sports offers and regular team and corporate events as well as other attractive benefits.

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