QA Operations Leader – Compliance & Quality Impact

Stryker; Irvine (CA); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Health benefits

Dental insurance

Vision insurance

Retirement plan

ESPP

Life & AD&D

Wellbeing program

Job summary

Stryker in Irvine, CA is seeking an Associate Manager, Quality Assurance to lead a Quality Operations team delivering quality excellence across manufacturing and business functions.

You will ensure adherence to quality standards, regulatory requirements, and customer expectations while fostering a culture of engagement and accountability. Strong leadership and problem-solving skills are required to drive continuous improvement.

Qualifications

• Bachelor’s degree in engineering or science.
• Minimum 6+ years in a regulated manufacturing environment.
• Expert knowledge of regulatory requirements and audits.
• Experience with quality tools and problem solving.

Responsibilities

• Lead and develop a Quality Engineering team across manufacturing and partners.
• Ensure compliance with quality standards, regulatory requirements, and customer expectations.
• Coach, develop, and retain talent to align with business needs.
• Collaborate with site leaders to improve quality systems and processes.
• Support internal and regulatory audits and inspection readiness.
• Oversee investigations, CAPAs, and deviations with timely resolutions.
• Monitor metrics and drive quality improvements to enhance product quality and efficiency.

Skills

Quality leadership

Regulatory knowledge

Quality systems

Audit & inspection

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

SPC

FMEA

Root cause analysis

Poka-yoke

Six Sigma

Job description

Stryker in Irvine, CA is seeking an Associate Manager, Quality Assurance to lead a Quality Operations team delivering quality excellence across manufacturing and business functions.

You will ensure adherence to quality standards, regulatory requirements, and customer expectations while fostering a culture of engagement and accountability. Strong leadership and problem-solving skills are required to drive continuous improvement.