Job details

MDR, Document Control Specialist

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.

Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. 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 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

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: 262-439-1894.