Job Description

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