Staff Quality Compliance Engineer

About the role

Stryker is hiring a Staff Quality Compliance Engineer in Irvine, CA, to support global regulatory compliance across the product lifecycle. The role provides technical leadership for standards and regulations management, keeping medical device products and quality systems aligned with evolving global regulatory requirements. It works closely with cross-functional teams to assess regulatory changes, evaluate their impact and implement compliance actions. The position is onsite.

Key responsibilities

• Lead the Standards & Regulations Management Compliance program as Division Process Owner, aligning processes and compliance activities across divisions.
• Monitor and identify new or revised global regulatory requirements, standards and guidance applicable to medical devices and quality systems.
• Interpret regulatory requirements and standards and guide product development, sustaining engineering and quality management teams.
• Conduct gap assessments comparing new or updated regulations and standards to existing requirements and processes.
• Evaluate the impact of regulatory and standards changes on commercialized products and quality management system processes.
• Develop and implement compliance action plans to maintain product and quality system conformity.
• Partner with cross-functional teams to complete required documentation according to company procedures.
• Support internal and external audits as a subject matter expert and review technical documentation, test protocols and reports for regulatory conformity.

Required profile

• Bachelor's degree in Engineering or a related discipline.
• Minimum 4 years of experience in regulatory compliance, quality, engineering or a related function.
• Experience in the medical device, healthcare or regulated industry.
• Experience performing regulatory impact assessments and standards gap analyses.
• Knowledge of global medical device regulations and international standards.

Preferred qualifications

• Experience supporting internal and external regulatory or quality audits.

Salary range: $102,700 - $171,100 USD per year; travel percentage: none.