As Quality Management System (QMS) Manager (m/f/x) you are responsible for establishing, maintaining, and continuously developing an effective Quality Management System in compliance with applicable medical device regulations. * You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements * You plan, drive, and document risk management activities across processes and projects * You bring extensive years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry * You possess solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements * You are familiar with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management
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