Group Manager Quality
Core
Lead the evolution of the Quality Management System (QMS) and oversee operational quality activities for a medical device organization developing cancer care software.
Role type
Group Manager Quality (Medical Device)
Builds
Scalable, compliant quality systems and processes for a medical device company
Domain
Medical Device / Software for Cancer Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management in medical devices, ISO 13485, MDR, MDSAP, QMSR, ISO 14971 risk management, Lead Auditor, people management, eQMS implementation, software lifecycle processes (IEC 62304)
Preferred skills
Experience with AI/ML data management in quality, optimizing eQMS solutions
Technologies
eQMS platforms, IEC 62304
Responsibilities
Drive QMS evolution focusing on simplicity and scalability, strengthen and streamline quality processes, lead and develop the quality team, oversee operational quality activities (CAPA, nonconformance, change control, audits, supplier quality), partner with cross-functional teams on quality practices, support validation and compliance for software systems, contribute to quality processes in AI/ML/data management, ensure compliance with regulatory frameworks
Seniority
Senior, hands-on IC with direct reports