Corporate Sterilization and Microbiology Specialist

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.

Oversee sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex Medical, as well as purchased products labeled and sold by Teleflex Medical. Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods and facilities, microbiological controls, and biocompatibility studies. Evaluate new products, including custom and made-to-order kits, as needed to support manufacturing and Regulatory submissions.

1. Prepare and execute sterilization validations and test protocols/reports for internal and external Teleflex Medical sterilization facilities. 2. Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market. 3. Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods and biocompatibility of Teleflex products. 4. Evaluate the effectiveness of existing sterilization methods on custom or made-to-order kits. 5. Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives. 6. Maintain and execute a sterilization and biocompatibility program/policy for Teleflex Medical to endure all products and processes comply with the regulatory standards. 7. Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products. 8. Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products. 9. Provide sterilization expertise during audits of internal and external sterilization suppliers according to a documented audit plan. 10. Provide oversight and ensure company-wide, consistent and compliant methods for the following: EO Residuals, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing. (These are considered “microbiological methods”.) 11. Train appropriate company personnel on biocompatibility, sterilization, and microbiological methods and processes as needed. 12. Ensure company documentation related to biocompatibility, sterilization, and microbiological controls are maintained and updated with most current regulations, standards, and industry practices. 13. Perform miscellaneous projects and duties at the direction of Quality Assurance and Manufacturing Management. 14. Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.

1. Strong communication skills (written and verbal) 2. Regulatory, cGMP, QSR knowledge base 3. Statistical knowledge (DOE, SPC, Sample comparison, etc.) 4. Computer literate (MiniTab, Word, Excel, etc.) 5. Negotiation and strong problem solving skills 6. Ability to communicate and operate effectively with multiple teams 7. Supplier audit skills 8. Knowledge/experience in EO and gamma radiation sterilization 9. Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability KNOWLEDGE/SKILL: * B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background * Minimum of 5 years of experience in sterilization of medical devices