ABTEILUNGSLEITUNG QUALITY MANAGEMENT SYSTEM (W/M/D), Potsdam - ROK
Core
Leading the Quality Management System (QMS) department and driving the development of a scalable, digital QMS for a medical device manufacturer specializing in neurosurgical implants.
Role type
Department Head, Quality Management System
Builds
International regulatory compliance and certified quality processes for neurosurgical hydrocephalus shunts
Domain
Medical Devices / Neurosurgery / Regulatory Compliance
Required skills
Quality Management System leadership, Regulatory audit leadership (FDA, NMPA, MDSAP), ISO 13485 & EU-MDR expertise, Digital transformation of QMS, Team development, Strategic advisory
Preferred skills
Experience as Quality Management Representative (QMB), German and English fluency
Technologies
eQMS platforms, Digital transformation tools
Responsibilities
Lead the QMS department and develop digital processes, Oversee international regulatory inspections and certification audits, Drive QMS evolution and digitalization initiatives, Translate international regulations into internal processes, Develop and mentor the team, Advise senior management on regulatory strategy