Quality Operations lead
Core
Leading QA Operations to support production line controls, batch documentation, and deviation management in a GMP environment.
Role type
Quality Operations Lead
Builds
Production line controls, batch documentation, and quality audit processes
Domain
Medical device manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, quality system management, quality audit execution, production line control, batch documentation, deviation management, project leadership, process thinking, prioritization, decision-making
Preferred skills
Packaging materials and artwork experience, ISO 13485 certification
Technologies
Standard computer applications
Responsibilities
Lead QA Operations department, execute line controls and release, prepare batch documentation, support production deviations, coordinate daily quality activities, manage quality instructions and procedures, lead ad-hoc projects, ensure GMP work processes
Seniority
Senior, hands-on IC
