Sr Manager, Quality Assurance
Core
Ensuring compliance with quality objectives and regulatory requirements for medical device combination product manufacturing and technology transfers.
Role type
Senior Manager, Quality Assurance
Builds
Medical device combination products
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLPs compliance, QA principles, regulatory requirements, CAPA management, audit coordination, contract manufacturer management, new product start-up support, statistical process control
Preferred skills
Six Sigma/DMAIC, Risk Management (HACCP/FMEA), Computer System Validation (CSV), ASQ certification
Technologies
Electronic records systems, CSV tools
Responsibilities
Manage QA personnel and performance reviews, implement changes to controlled documents (SOPs), review manufacturing and environmental monitoring data, lead investigations and CAPA, coordinate compliance audits, interface with contract manufacturers and regulatory agencies
Seniority
Senior, hands-on IC with management responsibilities
