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