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. The role provides leadership and direction for quality assurance activities with a strong focus on compliance, risk prevention, continuous improvement and operational effectiveness, ensuring adherence to Stryker Corporate and SGS requirements, Quality System Regulations and applicable industry standards.

Key responsibilities

• Lead and develop a Quality Engineering team, guiding manufacturing and cross-functional partners and 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 team through coaching, development and effective employee relations.
• Recruit, develop and retain talent aligned with business needs and future growth.
• Partner with site leaders and functional teams to establish, maintain and improve quality systems, standards and compliance processes.
• Support internal, external and regulatory audits to maintain site certifications and inspection readiness.
• Oversee investigations, nonconformances, CAPAs and product/process deviations, ensuring timely resolution and risk mitigation.
• Monitor quality performance metrics and drive quality improvement initiatives.

Required profile

• Bachelor's degree in an engineering or science-related discipline.
• At least 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 managing inspections and audits by governing or regulatory bodies.
• Preferred: experience in FDA-regulated medical device, pharmaceutical or life sciences environments; Business Management or MBA; demonstrated success building and leading high-performing teams; proven ability to lead change initiatives.

Required skills

• Quality tools such as SPC / Process Control, FMEA, problem solving and root cause analysis, Poka-Yoke, or other Six Sigma tools.

What we offer

• Salary range of $118,000 - $196,600 USD per year.
• 10% travel.