Position Title
Manager Sterility Assurance
SBU
Corporate
Department
Quality Assurance
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Oversee all sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex Medical, as well as products purchased by Teleflex Medical. Review and approved sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products, including custom or made-to-order kits, for impact of sterilization.
Qualification Requirements
Minimum 5 years experience in the bio-medical, device or pharmaceutical industry. Minimum 5 years experience on a sterilization and/or microbiology function commensurate with responsibilities outlined above Knowledge and understanding of US, European and international stands, guidance documents and regulations related to sterilization and microbiological methods and controls. Experience with operation and validation of ethylene oxide, radiation or other methods of sterilization. Knowledge and understanding of quality system documentation requirements.
Preferred Qualifications
Education; BS or BA degree in a technical or scientific discipline. Extensive industry experience may be suitable substitution for a bachelor's degree
Responsibilities
Prepare and execute sterilization validation test protocols and reports for all internal and external Teleflex Medical sterilization facilities. Evaluate impact of existing sterilization methods on new products or new product designs Evaluate impact of existing sterilization methods on new or modified manufacturing related changes. Evaluate impact of existing sterilization methods on custom or made-to-order kits. Evaluate alternative sterilation methods, facilities and processes as needed to support manufacturing objectives. Performs audits on internal and external sterilization suppliers according to documented audit plan. Provide oversight, and ensure company-wide, consistent and compliant methods for the following: EtO residuals: bioburden monitoring; environmental monitoring; clean-room practices; and pyrogen testing. Train appropriate company personnel on sterilization and microbiological methods and processes as needed. Ensure company documentation related to sterilization microbiological controls are maintained and updated with most current regulations, standard and industry practice. Approve change control documentation (i.e. DMR) as sterilization/microbiology representative Perform miscellaneous projects and duties at the direction of Quality Assurance and Manufacturing Management. Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures and housekeeping standards. Manage the sterilization and biocompatibility program for Teleflex Medical to ensure all the products and processes comply with the required standards Provide management for creating a sterilization strategy for all Teleflex Medical products Provide input for creating a strategy for biocompatibility testing to serve Teleflex Medical products
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