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 specifications.
Role type
Manager, Quality Assurance
Builds
Medical devices for interventional, diagnostic, and therapeutic procedures
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Management of quality engineers and technicians, knowledge of 21CFR Part 820 and ISO 13485, budget management, risk mitigation, conflict resolution, personnel hiring and training, problem-solving, analytical skills
Preferred skills
Oracle database usage, statistical analysis, spreadsheets, word processing
Technologies
Oracle, spreadsheets, word processing, database, statistical analysis software
Responsibilities
Ensure compliance with quality system regulations, provide resources to meet department objectives, resolve product quality and auditing problems, prepare quality status reports, manage department personnel, review risk management files
Seniority
Manager, hands-on leadership
