Quality Assurance Lead, Operations & Compliance

Stryker Corporation; Irvine (CA); Hybrid; USD 118,000 - 197,000; Full time

Job summary

Stryker Corporation in Irvine, CA is hiring an Associate Manager of Quality Assurance to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions. You will oversee compliance, CAPAs, audits, and continuous improvement initiatives, shaping a culture of accountability and quality ownership.

The role requires a Bachelor’s degree in engineering or science and 6+ years in a regulated environment, with expertise in SPC, FMEA, RCA, and

Qualifications

• Bachelor's degree in Engineering or Science required.
• 6+ years in a regulated manufacturing environment.
• Expert working knowledge of regulatory requirements and audits.
• Experience with quality tools (SPC, FMEA, RCA, Poka-Yoke).

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.

Skills

Regulatory knowledge

Quality improvement

Team leadership

Education

Bachelor's degree in Engineering or Science

Tools

SPC / Process Control

FMEA

Root Cause Analysis

Poka-Yoke

Job description

Stryker Corporation in Irvine, CA is hiring an Associate Manager of Quality Assurance to lead a high-performing Quality Operations team and drive quality excellence across manufacturing and business functions. You will oversee compliance, CAPAs, audits, and continuous improvement initiatives, shaping a culture of accountability and quality ownership.

The role requires a Bachelor’s degree in engineering or science and 6+ years in a regulated environment, with expertise in SPC, FMEA, RCA, and