Documentation Specialist
Date: Apr 3, 2024
Location: Chelmsford, MA, US
Company: Teleflex
Expected Travel: None
Requisition ID: 10151
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 Urology – The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
1. Roehrborn, Can J Urol 2017
Position Summary
The Document Control & Records Specialist will support the Quality Team and will be responsible for daily support activities related to document control and archiving. In this role you will store, manage, and track records, while ensuring the integrity, quality, and accuracy of all documentation.
Principal Responsibilities
• Assists the documentation process using Agile and SAP systems
• Maintains controlled documentation and records, maintains documentation databases
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures and processes.
• Maintains positive communication and collaborates with all levels at the site, customers, contractors, and vendors.
• Responsible for accurate data entry and maintenance of records.
• Performs other related duties and responsibilities as assigned.
• Audit support
• Cross- train to support organization as needed.
Education / Experience Requirements
• High School diploma (Associates degree prefered).
• 2 years of experience in positions that require documentation, training and records retention environment.
Specialized Skills / Other Requirements
• Proficient with Microsoft Office, including Word, Excel, Powerpoint and Outlook.
• 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
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
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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: 877-880-8588 or Talent@Teleflex.com.
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.
Nearest Major Market: Boston