In your role as a Quality Specialist (m/f/d) you will be responsible for implementation and maintenance of the local Quality Management System for medical devices and medicinal products according to EU and local regulations in cooperation with the Q&R EMEA North Team. **Your tasks** + Modification/adaption of corporate requirements according to national/local needs + Establishing, implementation, maintenance, and improvement of processes + Taking care of regulatory compliance for national necessary business processes + Tracking of CAPA’s + Assist Q&R German Team and responsible person (RP) as contact partner for audits by the notified body, health authorities or corporate functions + Track, follow up and closure of complaints via QTrak. Share applicable information with Q&R German team and other departments + Preparation of management review in cooperation with the German Q&R Team + Qualification and maintenance of critical suppliers, in cooperation with procurement, German quality team, RP and relevant departments + Training activities, e.g. quality introduction for new employees + Performance of self-inspections, internal/external audits in cooperation with German Quality Team **Your profile** + Successfully completed vocational training with professional experience or bachelor’s degree in business, economics, scientific studies, or similar + At least 3 + years professional experience in quality management of medical devices or medicinal products respectively similar activity in the regulated environment + Knowledge of structure of Quality Management System + ISO 9001 / ISO 13485; MDR; Good Distribution Practice (GDP) + Reliable, proactive and solution oriented with very good communication skills + Highly professional attitude characterized by a result, quality, patient, and customer-oriented working style + Fluent in German and English, both in written and spoken