Staff Quality Engineer, Microbiology and Sterilization

Staff Quality Engineer, Microbiology and Sterilization

Irvine, CA

Join Stryker's Quality team in a role focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. This position provides technical leadership supporting product development, manufacturing operations, quality systems, and regulatory requirements. The role works closely with cross-functional teams, external laboratories, and suppliers to ensure microbial control strategies, sterilization processes, and testing activities remain compliant with applicable standards and regulations.

What You Will Do

• Lead sterilization process development, validation, and requalification activities for new and existing products.
• Serve as the 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.
• Manage sterility assurance level maintenance and ensure requalification activities are completed according to 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 activities.
• Support regulatory inspections and internal, external, and supplier audits while providing technical guidance to research and development, manufacturing, quality, and regulatory teams.

What You Will Need

Required Qualifications

• Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field.
• Minimum 4 years of experience in microbiology, sterilization, or related quality engineering roles within a regulated industry.
• Experience working within FDA, ISO, GMP, or other regulated quality system environments.
• Experience with sterilization technologies such as Ethylene Oxide (EtO), Gamma, Electron Beam, or other terminal sterilization methods.

Preferred Qualifications

• Knowledge of microbiological testing, and biocompatibility evaluation principles.
• Experience supporting regulatory inspections, supplier audits, and quality system audits.
• Experience with risk management activities and validation of microbiological or sterilization processes.

• $95,800 - $159,600 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.