Quality Manager Medical Devices (m/w/d)

Welcome to (K)leben! We are pleased that you are interested in Lohmann, the specialist in adhesive solutions. Our success story began more than 170 years ago. We are still today a family-run company with social responsibility. And we are proud to be a reliable partner for our customers with pioneering technologies. At our headquarters in Neuwied, we produce high-tech adhesive tapes for the industry in close cooperation with our around 1,700 colleagues worldwide in over 20 countries of the world.

• Construction, implementation, maintenance and further development of product and process development for medical devices taking into account compliance with normative (EN ISO 13485) and legal requirements (MDR, FDA) • Contact person for quality-relevant questions for all departments, management, customers and suppliers • Preparation, implementation and follow-up of internal and external audits and supplier audits • cooperation in product development projects, in particular in the development and creation of the content and structure of technical documentation, in particular risk management shares (DIN EN ISO 14971) • Close cooperation with Regulatory Affairs on the global regulatory transport capability of our medical devices (standard and law monitoring, planning and implementation of regulatory requirements) in the regions of Europe and the USA

(m/w/d) with additional training as a quality manager or comparable qualification • knowledge and experience in the handling of the common standards (EN ISO 13485, DIN EN ISO 14971,...). Ideally with audit experiences • Experience in project management desirable • Mind. 5 years of professional experience in quality management • First experience in the implementation of medical device development • First experience in communication with licensing bodies, authorities, sales partners, suppliers and customers in representation function. • Routinized handling of MS-Office and support software in the area of Quality Management • Very good knowledge of German and English • Problem-solving behavior, independent solution finding and realization JOBV1_EN