Senior Quality System Manager, CAPA - NV - Irvine, CA (Onsite)
Core
Lead the Corrective and Preventive Action (CAPA) program and oversee Quality Management System (QMS) activities to ensure regulatory compliance and product quality in medical device manufacturing.
Role type
Senior Quality Systems Manager (CAPA)
Builds
Quality management systems and compliance frameworks for neurovascular medical devices
Domain
Medical device / Neurovascular / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA governance, audit readiness, QMS process management, risk escalation, regulatory compliance interpretation, cross-functional partnership, performance metrics analysis, process improvement
Preferred skills
TrackWise eQMS, Lean Green Belt, Microsoft Visio, Agile methodologies, training program development
Technologies
TrackWise, Microsoft Visio
Responsibilities
Lead CAPA review board activities and oversee timely closure of actions; Provide leadership and coaching to the CAPA team; Oversee QMS processes and continuous improvement initiatives; Direct audit and inspection readiness activities; Develop and maintain quality programs and procedures; Partner with business teams to identify compliance risks and implement improvements; Monitor quality system metrics and communicate results to leadership
Seniority
Senior, hands-on IC with people leadership
