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

Medtronic•Irvine, CA

4d•$149,600 - $224,400•Onsite

About The Position

The Senior Quality Systems Manager provides leadership and oversight for Quality Management System (QMS) activities with primary responsibility for Corrective and Preventive Action (CAPA) governance, audit readiness, and compliance initiatives. This role leads the CAPA team and partners with cross-functional stakeholders to drive the effectiveness of quality programs, strengthen quality system performance, support regulatory inspections, and ensure compliance with applicable regulatory and internal requirements.

Requirements

Bachelor's degree and 7+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience; OR Advanced degree and 5+ years of relevant quality, compliance, or quality systems experience with 5+ years of people leadership experience.
Experience leading Corrective and Preventive Action (CAPA) governance processes, including review boards, performance metrics, risk-based prioritization, escalation management, and CAPA closure oversight.
Experience leading or supporting audits and regulatory inspections, including preparation, execution, inspector interaction, and response to findings.
Experience working within a regulated industry environment and applying Quality Management System (QMS) requirements to maintain compliance.
Experience interpreting and implementing regulatory, governmental, and quality system requirements within business processes.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industries.
Experience using TrackWise or comparable electronic Quality Management System (eQMS) platforms.
Experience developing and delivering quality system, compliance, or process improvement training programs.
Proficiency with Microsoft Visio for process mapping, workflow design, and documentation.
Lean Green Belt, Design for Reliability and Manufacturability (DRM) Green Belt, or similar continuous improvement certification.
Experience applying Agile methodologies and leading cross-functional process improvement initiatives.

Responsibilities

Lead the CAPA program, including CAPA review board activities, risk escalation, performance monitoring, prioritization, and oversight of timely and effective CAPA execution and closure.
Provide leadership, coaching, and direction to the CAPA team to ensure successful execution of quality initiatives, compliance objectives, and business priorities.
Oversee ongoing Quality Management System (QMS) processes and continuous improvement activities to maintain compliance and drive operational effectiveness.
Direct audit and inspection readiness activities and coordinate responses to internal, external, customer, and regulatory audit observations and findings.
Develop, maintain, and improve quality programs, systems, processes, and procedures that support compliance with applicable regulations, standards, and company policies.
Partner with business and functional teams to evaluate process performance, identify compliance risks, and implement sustainable process improvements.
Monitor quality system metrics and trends, communicate performance results to leadership, and drive actions that improve quality system effectiveness.
Coordinate quality-related support for legal, regulatory, and government inquiries while promoting best-practice sharing and standardized quality processes across the organization.