Senior Manager, Quality Management Systems
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Job Location:
Irvine, CA - USA
Monthly Salary:
$ 149000 - 253500
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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. Youll 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
Bachelors 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.
$149000 - $253500 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 contractors legal duty to furnish information.Required Experience:
Senior Manager
Key Skills
- Attorney At Law
- Customer
- Customer Support
- Excel
- Assembling
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
