Director, Quality Operations
Core
Strategic and operational leadership for all Quality functions at a large-scale medical device manufacturing site, ensuring regulatory compliance and enabling business growth.
Role type
Director, Quality Operations
Builds
Medical device manufacturing site operations compliant with global regulations
Domain
Medical Devices / Manufacturing Quality
Required skills
FDA QSR, ISO 13485, MDR, risk management, validation, quality engineering, manufacturing quality leadership, audit leadership, organizational change management, budget ownership, performance metrics
Preferred skills
Site start-ups, transfers, rapid-growth operations, large-scale manufacturing expansions
Technologies
None stated
Responsibilities
Lead Quality Engineering, Quality Assurance, Quality Control, Incoming Quality, and Quality Systems functions; Partner with Global Quality, Operations, Supply Chain, Regulatory, and Engineering teams; Develop and execute site Quality strategy; Serve as primary Quality representative during FDA inspections, MDSAP audits, ISO 13485 certification audits, customer audits, and corporate assessments; Provide executive oversight of CAPA, nonconformance management, management review, audits, complaints, validation, environmental monitoring, training, and release processes; Lead quality readiness activities for site expansion, capacity growth, inspections, certifications, and commercialization programs; Ensure robust risk management practices and data-driven decision making; Own multiple quality budgets and establish performance metrics
Seniority
Director, strategic & operational leadership
