.Work Shift:DAYWork Schedule:Why Merit?At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.ESSENTIAL FUNCTIONS PERFORMED1. Supports New Product Development, Acquisition and Operations Engineering teams creating and implementing plans for sterility assurance activities to support new/modified products/processes for the assigned region/site.2. Communicates and interfaces with contract sterilizers, laboratories, and internal customers (R&D, Operations, Regulatory Affairs and Sterility Assurance) as required to effectively manage effectively manage day to day processing requirements.3. Performs and documents product qualifications into existing EO sterilization cycles using the appropriate standards development/modification of sterilization processes for new or existing products.4. Performs and documents product adoptions into existing EO cycles, including selection and justification of master product.5. Develop, review and approve sterilization process qualifications and routine dose audits.6. Develop, qualify and implement microbiological test methods to support sterility assurance of products.7. Review sterilization and laboratory documentation to ensure compliance with procedures.9. Support cleanroom and installation and qualification activities including protocol development, review and/or approval.10. Provide environmental monitoring inputs, conduct and/or manage testing (contract testing laboratories), analyze data and write test reports as applicable.11. Review sterilization and environmental documentation to ensure compliance with procedures and applicable regulations.14. Lead or participate in sterility assurance technical audits for Merit manufacturing sites and for contracted services.15. Keep abreast of current technologies and regulatory standards.16. Align to and drive for global standardization and harmonization specific to the policies, procedures and working instructions that produce product sterility assurance and regulatory compliance.17. Drives ongoing sterilization programs and projects for Merit harmonizing, where possible, the quality systems and processes used throughout Merit. All changes to the Merit sterilization program should align within Merit corporate quality goals, while maximizing Merit productivity and maintaining a high level of regulatory compliance.18. Actively coordinate, train and develop a staff of sterility assurance professionals dedicated to ensuring the product release, change control, validation/adoptions, contract management, experimentation and all associated activities deliver customer satisfaction through product quality, process efficiency, sterility assurance and national and international regulatory compliance.19