Work Flexibility: OnsiteStaff Quality Engineer, Microbiology and Sterilization Irvine, CAJoin Stryker's Quality team in a role focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. This position provides technical leadership supporting product development, manufacturing operations, quality systems, and regulatory requirements. The role works closely with cross-functional teams, external laboratories, and suppliers to ensure microbial control strategies, sterilization processes, and testing activities remain compliant with applicable standards and regulations.
What You Will Do:
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.
What You Will Need
Required 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 within 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.
Preferred
Qualifications:
Knowledge of microbiological testing, and biocompatibility evaluation principles.
Experience supporting regulatory inspections, supplier audits, and quality system audits.
Experience with risk management activities and validation of microbiological or sterilization processes.$95,800 - $159,600 USD Annual
Travel Percentage:
10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
Summary
Location: Irvine, California
Type: Full time
