Documentation Specialist

Date: Nov 19, 2020

Location: Wyomissing, PA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3083

 

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.

 

Vascular Access – 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 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.

Position Summary

<span style="font-family:"Arial",sans-serif">Create, revise, review and release Device Master Records, Material Master configurations, and documentation associated with product lifecycle management required to purchase, manufacture, and distribute medical device products

Principal Responsibilities
  • Serve as Change Analyst and/or Data Steward within the PLM, ERP and UDI database systems - Agile, SAP, Lansa.
  • In coordination with engineering teams, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP and UDI database systems - Agile, SAP, Lansa.
  • Review DMR-related documents and attachment files submitted for creation or changes.  Standardize format, proofread for errors/clarity and verify configuration.
  • Review change management activities for adherence to applicable change management procedures and cross-functional approval levels.
  • Create or revise product labeling contained within specific software systems (LabelView, Bartender, etc.) as required.
  • Perform proofreading of product labeling in coordination with the labeling team, to ensure adherence to internal labeling procedures, accuracy, completeness and formatting.
  • Follow regulatory requirements, internal procedures and the most recent and best practice guidance available in the areas of Design Control, DMR, change management, and inspection. 
  • Create or revise inspection documentation in the PLM and ERP database systems - Agile, SAP.
  • Process electronic DHF documents in the PLM database.  Review documents for formatting, clarity and adherence to GDP.
  • Generate/analyze metrics associated with the PLM database and other department work, as required.
  • Provide other department support as required by immediate supervisor.
  • Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Education / Experience Requirements
  • HS Diploma or equivalent
  • Experience or AS - technical discipline preferred
  • 0 - 4 years experience in documentation, data analysis or database systems
Specialized Skills / Other Requirements

 

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.

© 2020 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Reading PA