Associate Manager, Quality Assurance

Stryker; Irvine (CA); On-site; USD 116,000 - 193,000; Full time

Benefits offered by this job

Health benefits

Dental insurance

Vision insurance

401(k) plan

Health Savings Account (HSA)

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in Irvine, CA is seeking an Associate Manager, Quality Assurance to lead a high-performing Quality Operations team. You will drive quality excellence across manufacturing and business functions, guiding QA activities to ensure compliance with Quality System Regulations and industry standards.

You will recruit and develop talent, partner with site leaders to improve quality systems, and support audits to maintain certifications.

Qualifications

• Bachelor's 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.

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 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.

Skills

Leadership

Quality management

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

SPC

FMEA

Root Cause Analysis

Poka-Yoke

Job description

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.

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.

US30: $116,100 - $193,400 USD Annual

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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.