Lead Quality Engineer Microbiology & Sterilization

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

Job summary

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will work with cross-functional teams, suppliers, and external labs to ensure microbial control and validated sterilization methods.

The role requires experience in sterilization technologies (EtO, Gamma, electron beam) and a strong quality systems background aligned with FDA/ISO/GMP standards. Travel around 10% is expected.

Qualifications

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

Responsibilities

• Lead sterilization process development, validation, and requalification activities for new and existing products.
• Serve as SME for sterilization methods, microbiology programs, and biocompatibility requirements.
• Develop and maintain microbiological test methods including bioburden, endotoxin, and environmental monitoring.

Skills

Sterilization methods

Microbiology knowledge

Regulatory compliance

Education

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

Tools

EtO sterilization

Gamma irradiation

Electron beam sterilization

Job description

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will work with cross-functional teams, suppliers, and external labs to ensure microbial control and validated sterilization methods.

The role requires experience in sterilization technologies (EtO, Gamma, electron beam) and a strong quality systems background aligned with FDA/ISO/GMP standards. Travel around 10% is expected.