Senior Manager, Quality Management Systems

Senior Manager, Quality Management Systems

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.

What You Will Do

• Leverage full QMS expertise to assess the impact of proposed changes across the broader ecosystemensuring 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 You Will Need

Required Qualifications

• Bachelor's degree required. Preferred to be in engineering, life sciences, or related field.
• Minimum 10 years of relevant experience, including 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).

Preferred Qualifications

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

$149,000 - $253,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.