QA Engineering Lead – Quality & Compliance

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 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.