Staff Quality Engineer, Microbiology and Sterilization

Work Flexibility: Onsite

Staff Quality Engineer Microbiology and Sterilization

Irvine CA

Join Strykers 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

• Bachelors 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.

• $95800 - $159600 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 contractors legal duty to furnish information.