Document Control & Training Lead

Date: Aug 4, 2022

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 6704

 

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 Lead is responsible for tasks that drive the timely release and change of product documentation and supporting data throughout the lifecycle of products. This position provides supervision of the Configuration Management (CM) team and supports day-to-day planning and operations to ensure the team meets its required level of service. Additionally, this position ensures projects receive Configuration Management team support and provides mentoring and guidance to cross-functional groups in solving complex problems related to Configuration Management. This position directly contributes to the efficiency of end-to-end Operations by building and maintaining strong cross-functional relationships and by using critical thinking to identify and understand complex problems and leading efforts to implement appropriate solutions.

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
•    Support development of new documentation and provide detailed reports, queries, or summaries in support of various cross-functional projects and initiatives
•    Participate in the development of new documentation or the remediation of existing documentation for quality system processes to meet new and changing requirements or to address gaps in the current system
•    Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements
•    Ensure procedures are in place to classify and maintain appropriate records across all areas of the Quality System
•    Utilize visual management and participate in problem-solving, metric reporting/improvement, and other various projects, as assigned
•    Act as the site point of contact for PLM User Account Management and coordinates and aligns training requirements with Quality Systems Training personnel
•    Act as the site point of contact for PLM configuration changes and coordinates with IT to implement changes
•    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
•    A minimum of seven 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

•    Ability to manage a team with often competing priorities and varying skillsets
•    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
•    Advanced database skills and experience with PLM and ERP software
•    Ability to effectively execute projects and related activities with appropriate priority required
•    Excellent critical thinking skills & ability to identify and solve problems of moderate scope & complexity
•    Ability to function as part of a team and achieve results through open collaboration with others 
•    Results-oriented with the ability to be accountable to the achievement of both individual and team goals
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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 measurement equipment and 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.


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