ABTEILUNGSLEITUNG QUALITY MANAGEMENT SYSTEM (W/M/D), Potsdam - ROK
Core
Leading the Quality Management System (QMS) department and driving the evolution of a scalable, digital quality management system for a medical device manufacturer.
Role type
Department Head, Quality Management System
Builds
International scalable QMS, digital quality processes, and regulatory compliance frameworks
Domain
Medical Devices / Neurosurgical Implants / Regulatory Compliance
Required skills
Strategic leadership, QMS development, international audit leadership, regulatory requirement translation, team development, digital transformation
Preferred skills
Experience with QMB role, FDA QMSR knowledge, MDSAP expertise
Technologies
eQMS platforms, digital process tools
Responsibilities
Lead the QMS department and drive the development of leaner, digital processes; Oversee total responsibility for international authority inspections and certification audits (FDA, NMPA, MDSAP); Translate international regulatory requirements into effective processes and standards; Develop the team and foster cross-functional collaboration; Advise senior management on regulatory questions in a strategic context.
Seniority
Senior, hands-on IC with leadership responsibilities
