Senior Specialist Quality Assurance
Core
Ensures compliance to site level policies and procedures, leads quality system activities including CAPA and root cause analysis, and analyzes quality data to identify trends and assess process effectiveness.
Role type
Senior Specialist Quality Assurance (Quality Systems SME)
Builds
Consistent, high-quality documents, services, products, and processes
Domain
Healthcare / Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, CAPA management, root cause analysis, regulatory requirements monitoring, data analysis, project management, cross-functional collaboration, training and mentoring
Preferred skills
Healthcare industry experience, successful project delivery history, driving positive compliance outcomes
Technologies
None stated
Responsibilities
Define project goals and milestones; provide solutions to difficult problems ensuring compliance and consistency; lead quality system activities including CAPA and nonconformance investigations; analyze quality system data to identify trends; monitor evolving regulatory requirements; serve as a Quality Systems SME providing training and guidance
Seniority
Senior, hands-on IC with potential oversight of professionals and technicians
