Manager, Quality Assurance
Core
Providing management support, direction, and leadership to quality engineers and technicians to ensure medical devices are manufactured to required regulations and standards.
Role type
Manager, Quality Assurance
Builds
Medical devices for interventional, diagnostic, and therapeutic procedures (cardiology, radiology, oncology, critical care, endoscopy)
Domain
Medical Devices / Regulatory Compliance
Deliverable
infrastructure
Required skills
Management of quality engineers and technicians, knowledge of 21CFR Part 820 and ISO 13485, budget management, risk management, problem resolution, personnel hiring and training
Preferred skills
Statistical analysis, database management (Oracle), conflict management
Technologies
Oracle, spreadsheets, word processing, statistical analysis software
Responsibilities
Ensure compliance with quality system regulations, provide resources to meet department objectives, manage department budget, resolve product quality and auditing problems, prepare quality status reports, manage department personnel including hiring and training, review risk management files
Seniority
Manager, hands-on leadership
