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