Stryker · 1 week ago
Senior Manager, Quality Management Systems
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$149K/yr - $254K/yr
10+ years expStryker – Inari Medical is seeking a strategic Senior Manager, Quality Management Systems. In this role, you will lead the governance and advancement of the Quality Change Management subsystem, ensuring compliance, efficiency, and innovation while driving organizational readiness and operational excellence.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
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
Advanced degree in engineering, life sciences, or related discipline
Proven ability to think strategically and influence organizational direction
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase