QA Group Leader: Medical Device Testing
Core
Lead QA team and drive quality metrics, CAPA implementation, and audit support for medical device testing operations.
Role type
Senior QA Group Leader (Medical Device)
Builds
Quality data and compliance for medical device clients
Domain
Medical Device / Life Sciences / Quality Assurance
Deliverable
client delivery
Required skills
GMP and Medical Device Quality System (21 CFR Part 820, ISO 13485), ISO/IEC 17025, external audit support, root cause analysis, technical writing, supplier audits, internal audits, validation/change control, batch record review
Preferred skills
leadership, team building, multi-tasking, decision making, independent work
Technologies
None stated
Responsibilities
Delegate responsibilities and project ownership to direct reports, coach direct reports on challenges, interact with other departments to ensure quality data, work with laboratory groups to improve quality metrics and enable CAPA, perform major investigation writing/review and in-depth root cause analysis, assist with agency inspections, review/write QAU procedures
Seniority
Senior, hands-on IC with team leadership
