Staff Quality Engineer, Microbiology and Sterilization

About the role

Stryker's Quality team in Irvine, CA is hiring a Staff Quality Engineer focused on sterilization, microbiology and biocompatibility compliance across the product lifecycle. The role provides technical leadership for product development, manufacturing operations, quality systems and regulatory requirements, working closely with cross-functional teams, external laboratories and suppliers.

Key responsibilities

• Lead sterilization process development, validation and requalification for new and existing products
• Act as technical subject matter expert for sterilization methods, microbiology programs and biocompatibility requirements
• Develop, validate and maintain microbiological test methods, including bioburden, endotoxin and environmental monitoring programs
• Maintain sterility assurance levels and ensure requalification follows established schedules
• Review product, process and packaging changes, assess regulatory and quality impacts, and author technical documentation and risk assessments
• Investigate nonconformances, corrective and preventive actions and audit findings, and implement compliant remediation plans
• Maintain cleanroom contamination control validation strategies and oversee environmental monitoring
• Support regulatory inspections and internal, external and supplier audits, giving technical guidance to R&D, manufacturing, quality and regulatory teams

Required profile

• Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering or a related field
• Minimum 4 years of experience in microbiology, sterilization or related quality engineering roles in a regulated industry
• Experience in FDA, ISO, GMP or other regulated quality system environments

Required skills

• Sterilization technologies such as Ethylene Oxide (EtO), Gamma, Electron Beam or other terminal sterilization methods
• Preferred: knowledge of microbiological testing and biocompatibility evaluation, experience with regulatory and quality system audits, and risk management and validation of microbiological or sterilization processes

What we offer

• Salary range of $95,800 - $159,600 USD annually
• 10% travel percentage
• Onsite work flexibility