Document Control Support

Date: Apr 22, 2021

Location: Trenton, GA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3816

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This position supports the Teleflex OEM, Trenton’s Document/Data Change Management and Records Control systems by assisting with document control activities.

Principal Responsibilities

With direction of advanced Document Control personnel or Quality Engineer, this position is responsible for:
•    Primarily assist with basic DMO activities (SmartForms, NTP creation, obtaining approvals, dealing with Trade Compliance and loading trouble ticket to IT for SAP integration).
•    Releasing documentation for training purposes, including generation of training copies.
•    Implementation of new documents (and revisions) to controlled document locations and verification of retrieved obsolete revisions from Manufacturing. 
•    Maintaining record storage boxes and faciliating transfer to off-site storage location.
•    Proof reading documents, as requested by other team members.
•    Maintaining customer files as new documents are received or obsoleted. 
•    Maintaining external standards (specification folders), regulations and guidance. 
•    Maintaining controlled documents. 
•    Performing basic SAP tasks in display mode (i.e. inventory checks, data review).
•    Filing and maintaining submitted validation records (reports & protocols). 
•    Any temporary assigned task or project, as needed, by the department manager.
•    Adherence to procedures, quality standards, and regulatory requirements.
•    Assist in data gathering.

Education / Experience Requirements

High School Diploma or equivalent required.
College experience or Associate Degree preferred.
Knowledge of GMP/GDP preferred.
Experience in document control, records and information management or related field preferred.
1+ years of working in a manufacturing environment preferred.

Specialized Skills / Other Requirements

•    Abilitity to read and understand quality system documents is required.
•    Ability to read drawings and customer prints preferred.
•    Basic math skills and English/Metric conversions.
•    Must have high attention to detail and be highly organized.
•    Ability to work in Microsoft Office required, proficiency preferred.
•    Must have computer literacy.
•    Excellent verbal and written communication skills.
•    Must work well in a team environment.  
•    Ability to adjust to changing priorities and responsibilities. 
•    Knowledge of ISO 9001, AS9100 and/or ISO 13485 preferred. 
•    Knowledge of SAP system preferred.
•    Ability to learn SAP system required.  
•    Ability to work over-time if 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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