Staff Quality Engineer, Microbiology and Sterilization

Stryker · Irvine, CA

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QualityFull-time$96k–$160kCompany career page

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What they're looking for

Bachelor's degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field
Minimum 4 years of experience in microbiology, sterilization, or quality engineering in regulated industry
Experience working within FDA, ISO, GMP, or other regulated quality system environments
Hands-on experience with sterilization technologies such as EtO, Gamma, or Electron Beam
Knowledge of microbiological testing and biocompatibility evaluation principles
Experience supporting regulatory inspections, supplier audits, and quality system audits

What you'll be doing

Lead sterilization process development, validation, and requalification for new and existing products
Develop, validate, and maintain microbiological test methods including bioburden and endotoxin programs
Manage sterility assurance level maintenance and conduct scheduled requalification activities
Investigate nonconformances and implement compliant remediation plans with risk assessments
Support regulatory inspections and audits while providing technical guidance to cross-functional teams

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