Senior Manager, Quality Management Systems

Senior Manager, Quality Management Systems page is loaded## Senior Manager, Quality Management Systems locations:
Irvine, California time type:
Full time posted on:
Posted Yesterday job requisition :
R554924

Work Flexibility:
Onsite 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 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 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,
** 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. Master Control, Propel, Track Wise).
** 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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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