Stryker
Associate Manager, Quality Assurance
Irvine, California · Contract
Sponsorship not specified$118k-$197kDetected 6 days ago
Process ImprovementEmployee RelationsFDA RegulatoryMedical DevicesLeadershipProblem SolvingMentoring
About the role
- In this role, you will provide leadership and direction for quality assurance activities with a strong focus on compliance, risk prevention, continuous improvement, and operational effectiveness.
- This position plays a key role in delivering both compliance and business objectives, supporting product quality, process improvements, and overall organizational success.
- 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.
Responsibilities
- Lead and develop a Quality Engineering team, providing guidance and support to manufacturing and cross-functional partners while promoting a culture of quality and continuous improvement.
- Recruit, develop, and retain talent, aligning team strengths with business needs and future growth opportunities.
- Partner with site leaders and functional teams to establish, maintain, and improve quality systems, standards, and compliance processes.
- Support internal, external, and regulatory audits, helping maintain site certifications and inspection readiness.
- Monitor quality performance metrics and drive quality improvement initiatives that enhance product quality, reduce risk, improve efficiency, and support site and global business objectives.
- 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.
- Stryker is hiring an Associate Manager, Quality Assurance in Irvine, CA to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions.
Requirements
- Bachelors degree in Engineering or Science related discipline.
- Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by governing and/or regulatory bodies.
- Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, or other Six Sigma tools.
Compensation
- $118,000 - $196,600 USD Annual
Benefits
- Minimum of 6+ years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
- Experience working within FDA-regulated medical device, pharmaceutical, or life sciences environments preferred.
- Stryker is an EO employer - M/F/Veteran/Disability.
Equal opportunity
- Stryker Corporation is an equal opportunity employer.
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