Senior Quality Engineer, Microbiology & Sterilization

Stryker Group; 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

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.