Sterilization & Microbiology Specialist

Company: Teleflex
Location: Morrisville
Posted on: November 25, 2022

Job Description:

Expected Travel: Up to 10%
Requisition ID: 6937
About Teleflex Incorporated
Teleflex is a global provider of clinically effective 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, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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 Summary
Support all 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, and microbiological controls. Evaluate new products, including custom and made-to-order kits, for the impact of sterilization.
Principal Responsibilities

• Prepare and execute sterilization validations and test protocols/reports for all internal and external Teleflex Medical sterilization facilities.
• Provide support when evaluating the impact/efficacy of existing sterilization methods on new products or new product designs
• Evaluate the impact of new or modified manufacturing-related changes on existing sterilization methods.
• Maintain and execute a sterilization and biocompatibility program/policy for Teleflex Medical to ensure all products and processes comply with the regulatory standards.
• Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for Teleflex Medical products.
• Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products.
• Provide support for 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").
• Train appropriate company personnel on sterilization and microbiological methods and processes as needed.
• Ensure company documentation related to sterilization and microbiological controls are maintained and updated with the most current regulations, standards, and industry practices.
• 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.
  Education / Experience Requirements
  
  • 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.
    Specialized Skills / Other Requirements
    
    • Knowledge / experience in EO and gamma radiation sterilization
    • Regulatory, cGMP, QSR knowledge base
    • Statistical knowledge (DOE, SPC, Sample comparison, etc.)
    • Strong communication skills (written and verbal)
    • Ability to communicate and operate effectively with multiple teams
    • Negotiation and strong problem-solving skills
    • Computer literate (MiniTab, Word, Excel, etc.)
    • Ability to adapt to shifting priorities, work with minimal supervision, resolve problems/conflicts, and demonstrate solid reasoning ability
      Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
      Teleflex is the home of Arrow -, Deknatel -, Hudson RCI -, LMA -, Pilling -, R--sch -, UroLift - and Weck - - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R--sch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
      - 2021 Teleflex Incorporated. All rights reserved.

Keywords: Teleflex, Cary , Sterilization & Microbiology Specialist, Other , Morrisville, North Carolina