Associate Manager, Quality Assurance
Stryker
Summary
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. 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. You will be responsible for ensuring adherence to Stryker Corporate and SGS requirements, Quality System Regulations, and applicable industry standards while fostering a culture of engagement, accountability, and quality ownership. This position plays a key role in delivering both compliance and business objectives, supporting product quality, process improvements, and overall organizational success.
Job description
What you will do:
- 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.
- Ensure products, processes, and systems comply with Stryker quality standards, regulatory requirements, and customer expectations.
- Foster an inclusive, engaged, and high-performing team environment through coaching, development, and effective employee relations practices.
- 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.
- Oversee investigations, nonconformances, CAPAs, and product/process deviations, ensuring timely resolution and effective risk mitigation.
- Monitor quality performance metrics and drive quality improvement initiatives that enhance product quality, reduce risk, improve efficiency, and support site and global business objectives.
What you need:
Required
- Bachelors degree in Engineering or Science related discipline.
- Minimum of 6+ years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
- 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.
Preferred
- Experience working within FDA-regulated medical device, pharmaceutical, or life sciences environments preferred.
- Business Management or MBA is an advantage.
- Demonstrated success in building, leading, and developing high-performing, engaged teams is preferred.
- Demonstrated ability to execute organizational and functional strategies while leading and driving change initiatives, with a proven track record of influencing and implementing change at both the individual and team levels.
Requirements
- Bachelors degree in Engineering or Science related discipline.
- Minimum of 6+ years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
- 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.
- Experience working within FDA-regulated medical device, pharmaceutical, or life sciences environments preferred.
- Business Management or MBA is an advantage.
- Demonstrated success in building, leading, and developing high-performing, engaged teams is preferred.
- Demonstrated ability to execute organizational and functional strategies while leading and driving change initiatives, with a proven track record of influencing and implementing change at both the individual and team levels.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.