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. The focus of the role is the coverage of Computerised System Validation (CSV) and the correct consideration of regulatrory requirements within the implementation phase of ZEISS FIT4 SAP S/4Hana Project. * You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements * You ensure the compliant implementation and application of MED QMS requirements within SAP-supported processes in cooperation with teams * You possess solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
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