Senior Quality System Manager, CAPA - NV - Irvine, CA (Onsite)

Medtronic seeks a Senior Quality Systems Manager to lead Corrective and Preventive Action (CAPA) governance and quality management system activities for the Neurovascular operating unit. The role oversees CAPA team operations, audit readiness, compliance initiatives, and quality system effectiveness in a regulated medical device environment.

Responsibilities

• Lead CAPA program including review board activities, risk escalation, performance monitoring, and timely closure oversight
• Provide leadership and coaching to CAPA team to execute quality initiatives and compliance objectives
• Oversee Quality Management System processes and continuous improvement activities for regulatory compliance
• Direct audit and inspection readiness activities and coordinate responses to audit findings
• Develop and maintain quality programs, procedures, and systems aligned with regulatory standards

Requirements

• Bachelor's degree plus 7+ years quality/compliance experience with 5+ years people leadership; or advanced degree plus 5+ years experience with 5+ years leadership
• Demonstrated experience leading CAPA governance, review boards, risk-based prioritization, and closure oversight
• Experience preparing for and supporting regulatory inspections and audits with response management
• Working knowledge of Quality Management System requirements in regulated industry contexts
• Ability to interpret and apply regulatory and quality system requirements to business processes
• TrackWise or comparable eQMS platform experience preferred
• Medical device, pharmaceutical, or biotechnology industry background preferred