Documentation Control Specialist - MDR

Date: Jul 23, 2022

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6637

 

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

The Configuration Management Associate is responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the lifecycle of products and ensuring conformance to applicable MDR, QS and other applicable requirements. This position will evaluate and process electronic change orders for completeness and adherence to procedures and will ensure appropriate distribution and notification.

 

Principal Responsibilities

•    Subject matter expert in change control as it relates to product lifecycle
•    Facilitate the timely change, approval, and release of product documentation and data (PLM, ERP)
•    Maintain new Item Master set-up and other related data in applicable ERP
•    Prepare Quality records for electronic scanning and off-site archiving; administer the system for archiving and off-site storage of document control and data records in accordance with defined requirements
•    Generate, assign, update, and ensure accuracy of the Global Trade Identification Number (GTIN) information in the Data Sync Direct
•    Partner with Regulatory and Packaging/Labeling teams to oversee and manage IFU-to-Web process and ensuring MDR regulatory requirements are met and maintained
•    Support development of new product documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives
•    Provide inventory control and maintenance of the central document reference library, including standards and guidelines
•    Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements
•    Utilize visual management and participate in problem solving, metric reporting/improvement, and other various projects, as assigned
•    Apply best practices in change control, configuration management, and continuous improvements
•    Provide high-level customer service and support to specific cross-functional areas
•    Participate in and/or lead special projects, as assigned
•    Provide audit and training support, as requested
 

Education / Experience Requirements

  • Bachelor’s Degree preferred
  • The successful candidate will have a minimum of three years relevant experience and a high level knowledge of quality systems, compliance and change control requirements in a regulated industry.
  • Broad functional expertise in change control management

Specialized Skills / Other Requirements

  • Excellent written and oral communication skills
  • Detail oriented and self-directed with excellent time management skills
  • Working knowledge of quality systems and compliance in a regulated industry
  • Working database skills and experience with PLM and ERP software
  • Ability to work collaboratively and independently

Working Conditions / Physical Demands

  • Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
  • Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required
  • Ability to communicate clearly both in writing and using spoken communication, with or without assistance
  • Ability to read, comprehend, and appropriately act upon detailed written information at an advanced level, with or without assistance
  • Infrequent lifting of up to 20 pounds may be required

 

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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Boston