Senior Manager, Quality Management Systems

Stryker • Irvine, CA

4d • $149,000 - $253,500 • Onsite

About The Position

Stryker – Inari Medical is seeking a strategic Senior Manager, Quality Management Systems in Irvine, CA! In this onsite role, you will lead the governance and advancement of our Quality Change Management subsystem, ensuring every product, process, and documentation change strengthens compliance, efficiency, and innovation. You’ll be at the forefront of driving organizational readiness and operational excellence.

Requirements

• Bachelor’s degree required.
• Minimum 10 years of relevant experience, i ncluding experience within the medical device industry.
• Minimum 5 years of managerial experience in quality assurance.
• Strong knowledge of QMS regulations and standards (e.g., FDA CFR, ISO 13485, MDSAP, EU MDR).
• Experience with electronic QMS platforms (e.g. MasterControl, Propel, TrackWise).

Nice To Haves

• Preferred to be in engineering, life sciences, or related field.
• Advanced degree in engineering, life sciences, or related discipline.
• Proven ability to think strategically and influence organizational direction.

Responsibilities

• Leverage full QMS expertise to assess the impact of proposed changes across the broader ecosystem—ensuring compliance, operational excellence, and alignment across interconnected systems and processes.
• Lead the Quality Change Management subsystem to ensure all changes impacting product quality, compliance, or operations are systematically evaluated, approved, and implemented.
• Serve as Division Process Owner to align and advance change management processes across divisions.
• Develop and execute QMS strategies that enhance efficiency, support business growth, and enable innovation while maintaining regulatory excellence.
• Partner with cross-functional teams (R&D, Regulatory, Operations, Quality, and Marketing) to align on change implementation strategies, resources, and stakeholder expectations.
• Chair and facilitate Change Control Board meetings to drive timely, compliant decision-making and empower teams to embrace change.
• Implement digital solutions to streamline documentation, improve traceability, and ensure audit readiness.
• Drive continuous improvement initiatives to optimize system scalability and compliance.
• Lead and mentor a team of quality professionals, fostering a culture of accountability, growth, and excellence.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees