Associate Manager, Quality Assurance

About the role

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.

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.
• 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.

Requirements

• 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.

Qualifications

• 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.

Skills

• Strong leadership and management skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Experience with regulatory compliance and auditing.
• Knowledge of quality management systems and tools.

Benefits

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.