Sterility Assurance Specialist

Job Summary Prepare and execute sterilization related activities for medical device and pharmaceutical products. Support various Medline product divisions while assuring appropriate sterility assurance levels to comply with FDA regulations and ISO standards (e.g. 21 CFR Part 820 / 211, IS011135, ISO11137 etc.). Apply engineering, microbiology and chemistry principles to develop, support and troubleshoot sterilization processes and challenges across multiple modalities.Job Description Responsibilities : Coordinate and manage bioburden and dose audit programs for radiation sterilization families across multiple manufacturing facilities, ensuring compliance with regulatory and quality standards. Lead international project teams to align and execute radiation-related initiatives, including sterilization strategy development, process optimization, and technology transfers. Evaluate changes to radiation sterilizers, including equipment upgrades, process modifications, and facility relocations, to determine validation requirements and ensure continued sterility assurance. Collaborate with cross-functional stakeholders, including Quality, Regulatory, Engineering, and Operations, to support sterilization-related decision-making and risk assessments. Monitor and trend sterilization performance data, identifying opportunities for improvement and ensuring robust documentation and reporting. Coordinate sterilization activities among Medline and contract sterilization facilities for ethylene oxide and radiation modalities in order to maintain compliance to regulations and industry standards including 21 CFR Part 820, ISO 13485, ISO 11135, and ISO 11137. Design and execute sterilization projects including preparation of validation protocols and reports, review and analysis of test results to ensure correct acceptance criteria and prepare a final report for approval. Assign sterilization cycles to new products based on the review of materials, product construction, and packaging. Review the validated process to make sure the item can be sterilized in this process. Review sterilization process deviations and work with division QA to determine product disposition. Provide instructions to the sterilization facility for re-processing and any additional evaluation required prior to final release. Provide technical support as needed during audits of Medline facilities, sterile vendors, sterilization facilities, and contract laboratories to ensure compliance with regulatory requirements. Evaluate, coordinate and troubleshoot testing for ethylene oxide residuals and bioburden testing at internal and external test laboratories. Review and revise sterilization-related procedures as needed when a new sterilization process is added or there is a change in current process. Train contract sterilization vendors on Medline validation requirements and procedures. Develop and validate new process challenge devices for ethylene oxide sterilization cycles. Work on global cycle optimization efforts. Prepare and modify sterilization standard operating procedures. Qualifications : Bachelor’s degree with a scientific or engineering background. At least 2 years relevant experience in industrial sterilization of healthcare prod Strong understanding of ISO 11135 and ISO 11137. Strong understanding of microbiology principles related to terminal sterilization. Strong understanding of chemistry principles related to EO / ECH residuals. Ability to work safely in environments where hazardous chemicals may be encountered under corporate safety rules and requirements. Position requires travel up to 50% of the time for business purposes (within state and out of state). Preferred Qualifications : CISS (Certified Industrial Sterilization Specialist). Project Management Experience Smartsheet Experience Dosimetry Experience Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position : $79,560.00 - $115,440.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and / or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.