Document Control & Training Supervisor

Date: Sep 10, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4661

 

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

Lead the administration of the Document / Record Control and the Training systems of the Quality Management System in the Chelmsford Facility, by providing technical and supervisory subject matter expertise. 

Principal Responsibilities

•    Supervise personnel from the Document Control and Training departments.
•    Oversee the Document Control and Change Management processes which include, but not limited to the following:
o    Maintain engineering drawings, project reports, specification preparations, documentation, special catalogs, and files for unique projects.
o    Manage the process of assigment and monitoring of document numbers.
o    Update and revise operating procedures as approved through Change Management.
o    Manage the documentation process in Agile and SAP.
o    Manage distribution process of controlled documents.
o    Assist in the remediation of documentation files.
o    Provide support in editing and updating documents and electronic filing databases. 
o    Participate and manage data entry and maintenance of records.
o    Support the development of all types of documents and reports.
o    Provide training and mentoring to document control personnel on the change management process.
•    Lead and maintain the Training system via the following tasks:
o    Maintain the training database.
o    Generate Key Performance Indicators, KPI’s reports on associated on-time training and provide reports related to outstanding and delinquet training to management and supervisory personnel.
o    Provide training and mentoring to training personnel on the training process.
•    Provide expertise and service to external and internal customers in relation to the Change Management, Document Control and Training processes.
•    Participate and support the Internal Audit program.
•    Provide support during external audits and timely access to the documentation and records.
•    Perform additional tasks as applicable, as assigned by the Qulaity Assuracne Manager.
 

Education / Experience Requirements

•    High School diploma (Associates degree preferred).
•    4 years of experience in positions that require documentation and technical writing and exposure to a training environment.
 

Specialized Skills / Other Requirements

•    Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook.
•    Good negotiation, problem solving and project management skills.
•    Strong attention to detail and ability to meet deadlines.
•    Effective communication skills, both written and verbal.
•    Ale to work in a fast-paced dynamic environment.
•    Knowledge of Quality Management Systems under ISO 13485:2016
•    Experience in the medical device industry as an internal auditor.
•    Ability to define problems, collect data, establish facts, and draw valid conclusions. 
 

 

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