Remote Staff Quality Engineer, Microbiology & Sterilization

Stryker Corporation; Irvine (CA); Remote; Confidential; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will lead sterilization process development, validate methods, and ensure regulatory alignment with FDA/ISO GMP standards.

As SME for sterilization and biocompatibility, you will develop and maintain test methods, monitor environmental controls, and support audits and regulatory inspections.

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 in 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.

Responsibilities

• 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.

Skills

Sterilization

Microbiology

Biocompatibility

Regulatory knowledge

Quality engineering

Education

Bachelor's degree

Tools

EtO sterilization

Gamma sterilization

Electron beam

Job description

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will lead sterilization process development, validate methods, and ensure regulatory alignment with FDA/ISO GMP standards.

As SME for sterilization and biocompatibility, you will develop and maintain test methods, monitor environmental controls, and support audits and regulatory inspections.