MDR Sterilization Specialist
Teleflex

Job Info

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Expected Travel: None

Requisition ID:3087

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 Functions - The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary

Perform MDR gap assessments of sterilization/microbiological data for Teleflex Medical products. Review historical testing data in a variety of databases to determine applicability per the new MDR initiative. Produce a technical document summarizing the applicable testing and/or identifying remediation plans when gaps are detected. The specialist would perform the associated tasks for 24-36 months.

Principal Responsibilities

• Create technical documents that outline the applicable testing on file and/or outlines gaps to address product compliance. Work with other functions to determine appropriate sample(s) to produce an efficient and effective remediation plan compliant to MDR 2017/745.
• Perform gap assessments of products by evaluating device validation documents, test methods and procedures to determine the acceptance of test data. Review of historical data may also include gap assessments for any historical testing that was conducted on an inactive part of ISO 10993.
• Provide support when evaluating the impact/efficacy of existing sterilization methods on new products or new product designs
• Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization 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").
• Ensure company documentation related to sterilization and microbiological controls are maintained and updated with 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®, 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.

© 2020Teleflex Incorporated. All rights reserved.

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