Quality Assurance Manager
Core
Lead the Quality team and manage the Quality Management System (QMS) for an E-beam sterilization site serving medical device, pharmaceutical, and semiconductor industries.
Role type
Senior IC Quality Assurance Manager (Site Lead)
Builds
Sterilization and irradiation services for medical devices, pharmaceuticals, and semiconductors
Domain
Healthcare / Medical Devices / Sterilization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, QMS management, regulatory compliance (cGMP, FDA, ISO 13485, ISO 11137), CAPA management, audit hosting, change management, validation/qualification oversight
Preferred skills
QP qualification path, complex quality case resolution, global-local requirement translation
Technologies
Rodotron (electron accelerator), QMS software
Responsibilities
Lead and develop a 7-person Quality team; ensure QMS compliance and effective daily practice; host regulatory and customer audits; manage CAPAs, document control, and change management; represent Quality to authorities, Notified Bodies, and customers; contribute to site leadership decisions.
Seniority
Senior, hands-on IC with people leadership