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.

• 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