Senior QA Manager (Quality Systems)
Core
Manage the development and implementation of quality policies and programs for a continuous glucose monitoring (CGM) manufacturing site, ensuring compliance with FDA and ISO regulations.
Role type
Senior QA Manager (Quality Systems)
Builds
CGM devices for diabetes management
Domain
Medical device manufacturing / Biosensing technology
Deliverable
infrastructure
Required skills
MDSAP/ISO13485/FDA21CFR820(QMSR) compliance, audit management (internal/external), root cause analysis, statistical modeling (Six Sigma, Lean), operational management of high-volume manufacturing, team leadership, strategic planning
Preferred skills
Experience with document control, cross-functional communication, process improvement initiatives
Technologies
None explicitly listed
Responsibilities
Manage Quality System Compliance (Audit/CAPA/NCMR/Internal Audit/Management Review), design and maintain quality systems, establish operational objectives and work plans, lead management review for the site, lead audit readiness, supervise costs, methods, and staffing, participate in process or product investigations
Seniority
Senior, hands-on IC with people management