DHR Reviewer

Teleflex Exton , PA 19341

Posted 2 months ago

Date: Apr 15, 2020

Location: Exton, PA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 2426

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.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

Built on a history of innovation, our Arrow brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices for intraosseous vascular access and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

This position performs review of device history record documentation for incoming components, sub-assemblies, and finished devices.

Principal Responsibilities

  • Reviews incoming inspections forms for completeness and accuracy

  • Review sub-assembly and finished devices device history records (DHRs) prior to closure for completeness, accuracy, and compliance with specifications per applicable procedures

  • Maintains a record of DHR errors to elevate to supervisor for nonconformance generation if applicable

  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release

  • Coordinates with manufacturing department to ensure timely release of product

  • Assist in lot release activities when required

  • Support QC inspectors as backup when required

  • Perform related duties and responsibilities as required

Education / Experience Requirements

  • Associates degree strongly preferred

  • Two years of relevant QA/QC inspection experience

  • Experience in medical industry is preferred

  • Previous Cleanroom experience with GDP, GMP and regulatory

Specialized Skills / Other Requirements

  • Able to work in a high-performing team environment and possess a demonstrated ability to multi-task and accommodate changing priorities within compressed timelines

  • Superior verbal and presentation skills required

  • Requires familiarity with computers, Microsoft Office software, keyboarding, email and internet

  • Previous Quality Management System experience in an FDA regulated environment

  • Working knowledge of Medical Device industry a plus

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, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, 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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DHR Reviewer