Staff Quality Engineer, Microbiology and Sterilization

Stryker Corporation; Irvine (CA); Remote; Confidential; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking a Staff Quality Engineer focused on sterilization, microbiology, and biocompatibility compliance across the product lifecycle. You will lead sterilization process development, validate methods, and ensure regulatory alignment with FDA/ISO GMP standards.

As SME for sterilization and biocompatibility, you will develop and maintain test methods, monitor environmental controls, and support audits and regulatory inspections.

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 in 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.

Responsibilities

• 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.

Skills

Sterilization

Microbiology

Biocompatibility

Regulatory knowledge

Quality engineering

Education

Bachelor's degree

Tools

EtO sterilization

Gamma sterilization

Electron beam

Job description

Staff Quality Engineer, Microbiology and Sterilization – Irvine, CA

Join 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

• 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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.