Expected Travel: Up to 10%
Requisition ID: 11935
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position SummaryOversee sterilization and microbiological methods and processes related to products designed and manufactured by Teleflex Medical. Review and approve sterilization process qualifications, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products and changes, including custom and made-to-order kits, for impact of sterilization. Lead resources required to ensure compliance and quality related to sterility assurance processes.
Principal Responsibilities• Provide daily direction to the Sterility Assurance Department team consisting of varying levels of professionals to provide shared services to all business units across Teleflex.
• Responsible for maintaining sterilization databases for Teleflex while assuring sterility assurance compliance to relevant domestic and international standards.
• Manage resources to assure compliance with ISO standards for the various product lines and sterilization processes.
• Maintain and assist in managing the sterilization program/policy for Teleflex Medical to endure all products and processes comply with the regulatory standards.
• Support the maintenance of harmonized procedures used globally.
• Represent Teleflex and interface with auditors/investigators during audits as the SME for sterilization, microbiological and environmental controls for manufacturing facilities.
• Support the maintenance of harmonized procedures used globally.
• 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.
• Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
• Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives.
• Assess the impact of sterilization method related discrepancies and nonconformances.
• Manage department resources to provide microbiological expertise for environmental controls of existing and newly built cleanrooms and other controlled manufacturing environments.
• Assure annual requalification activities and quarterly dose audits/cobalt reloads are performed in a timely manner so that no supply chain interruptions occur.
• Provide oversight and ensure company-wide, consistent and compliant methods for the following: EO Residuals, dose audits, dose setting, dose mappings, dose augmentations, bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing. These are considered “microbiological methods”.
• Provide leadership and expertise to close CAPA's and non-conformances; reduce sterilization non conformances via creation of a quality culture.
• Lead teams associated with the annual requalification activities.
• Address issues arising from sterilization non-conformances. Create strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
• Train appropriate company personnel on sterilization and microbiological methods and processes as needed.
• Perform miscellaneous projects and duties as directed by the manager.
• Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
• Provide support to in-house microbiology and chemistry labs to provide efficient and compliant work processes.
• Develop/Maintain Procedures, templates, best practices to support department day to day activity in an efficient manner.
• B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 10 years of experience in sterilization of medical devices.
• M.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 5+ years of experience in sterilization of medical devices
• Minimum of 3 years of cross functional team leadership
• Minimum of 3 years of management of exempt employees which included technical oversight required
• Expertise and extensive knowledge in EO and gamma radiation sterilization
• Regulatory, cGMP, QSR knowledge base
• Statistical knowledge (DOE, SPC, Sample comparison, etc.)
• Supplier audit skills
• Computer literate (MiniTab, Word, Excel, etc.)
• Strong communication skills (written and verbal)
• Ability to communicate and operate effectively with multiple teams
• Negotiation and strong problem solving skills
• Ability to manage multiple tasks in order to meet/exceed deadlines
• Proven ability to adapt to shifting priorities, work with minimal supervision, to resolve problems/conflicts, and demonstrate sound reasoning ability
• Ability to effectively lead a team in order to meet project timelines
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.
Teleflex is an equal opportunities employer.
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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