- Collaborate with Global Procurement and the site/business unit quality team(s) to provide the appropriate sterility assurance support for purchased finished good (PFG's) and sterilization suppliers.
- Serve as a sterilization subject matter expert in Purchasing & Supplier Controls
- Prepare and execute sterilization validations and test protocols/reports for all internal and external Teleflex Medical sterilization facilities (as needed).
- 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.
- Provide support for sterilization practices 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 sterilization expertise during internal and external audits.
- Provide support to ensure contract manufacturers use 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.
- Provide sterilization, microbiological and environmental control expertise during supplier quality audits of critical suppliers/vendors (as needed).
- Provide expertise in support of process deviations.
- Support developing, implementing, and executing proactive supplier risk profiling to identify and eliminate potential supplier risks.
- Support sterilization supplier facility compliance audits to ensure sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
- Support developing and implementing management reporting tools for in-crisis suppliers and proactive risk monitoring.
- Perform miscellaneous projects and duties at the direction of Sterility Assurance Management.
- Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.
- B.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background and 3-5 years of experience in sterilization of medical devices. Msc. Qualification preferable but not essential.
- Knowledge / experience in EO and gamma radiation sterilization
- Regulatory, cGMP, QSR knowledge base
- Statistical knowledge (DOE, SPC, Sample comparison, etc.)
- Supplier audit skills
- 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.
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Associate Scientist, Sterility Assurance - Morrisville, United States - Teleflex
Description
Expected Travel:
Up to 25%
Requisition ID: 10194
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
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 sterilization/microbiological methods and process controls related to purchased products designed by Teleflex Medical and manufactured by contractors, products designed and manufactured by Teleflex Medical and/or purchased products labeled and sold by Teleflex Medical.
Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods, facility environmental controls and product microbiological controls (as needed).
Principal ResponsibilitiesWorking Conditions / Physical Demands
TRAVEL REQUIRED:
up to 30%
WORKING ENVIRONMENT:
☒ Office/Professional ☒ Plant/Manufacturing ☐ Remote/Field ☐ Laboratory
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:or
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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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