Senior Quality Engineer - Microbiology & Sterilization

Regulatory Jobs; Irvine (CA); Sur place; USD 96 000 - 160 000; Plein temps

Résumé du poste

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will provide technical leadership to product development, manufacturing, quality systems, and regulatory teams, collaborating with laboratories and suppliers to keep microbial control strategies and testing aligned with standards.

You will develop and validate microbiological methods (bioburden, endotoxin, environmental

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 with FDA, ISO, GMP, or other regulated quality system environments.
• Experience with sterilization technologies such as EtO, Gamma, Electron Beam, or other terminal sterilization methods.

Responsabilités

• Lead sterilization process development, validation, and requalification activities.
• 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.

Connaissances

Sterilization

Microbiology

Quality engineering

Formation

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

Description du poste

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer to lead sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will provide technical leadership to product development, manufacturing, quality systems, and regulatory teams, collaborating with laboratories and suppliers to keep microbial control strategies and testing aligned with standards.

You will develop and validate microbiological methods (bioburden, endotoxin, environmental