Senior Quality Engineer, Microbiology & Sterilization

Stryker; Irvine (CA); On-site; USD 96,000 - 160,000; Full time

Job summary

Stryker Group in Irvine, CA is seeking a Staff Quality Engineer focused on microbiology, sterilization, and biocompatibility compliance across the product lifecycle.

The role provides technical leadership to development, manufacturing, quality systems, and regulatory teams, coordinating with external laboratories and suppliers to ensure microbial control, validated sterilization processes, and compliant testing strategies.

Qualifications

• Bachelor's degree in a related field.
• 4+ years of experience in microbiology, sterilization, or related quality engineering roles.
• Experience in FDA, ISO, GMP, or other regulated environments.
• Experience with sterilization technologies such as EtO, Gamma, or Electron Beam.

Responsibilities

• Lead sterilization process development, validation, and requalification activities for new and existing products.
• Serve as the SME for sterilization methods, microbiology programs, and biocompatibility requirements.
• Develop, validate, and maintain microbiological test methods, including bioburden, endotoxin, and environmental monitoring.
• Manage sterility assurance level maintenance and ensure requalification activities are completed on schedule.
• Review changes; assess regulatory and quality impacts; and author technical docs and risk assessments.
• Investigate nonconformances, CAPAs, audits, and implement remediation plans.
• Maintain cleanroom contamination control strategies and oversee environmental monitoring.
• Support regulatory inspections and audits; provide guidance to R&D, manufacturing, quality, and regulatory teams.

Skills

Sterilization processes

Microbiology programs

Biocompatibility evaluation

Regulatory inspections

Education

Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field

Job description

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