Documentation Specialist II

Date: Feb 18, 2021

Location: Jaffrey, NH, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3452

 

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, Jaffrey’s Document/Data Change Management and Records Control systems by performing document control activities.

Principal Responsibilities

With direction of the advanced Document Control personnel or Supplier Quality Engineer, this position is responsible for:
•    Releasing documentation for training purposes, including generation of training copies.
•    Scanning & filing Engineering Change Notices (ECN) and any other Document Control record. Maintaining record storage boxes and facilitating transfer to Building 2 and/or off-site storage location.
•    Processing & controlling customer-supplied documentation (drawings/specification). Maintain customer files as new documents are received or obsoleted (a.k.a. Spec Review Process). 
•    Processing Visual Aid Standards through the Quality System for creation, review, change, or obsoletion.
•    Completing basic activities as SAP Master Data Steward (i.e. creation/change of Bills of Material, Routers, Inspection Plans).  
•    Provide support for internal and external audits by participating in Back or Front room activities as needed (such as document retrieval or document preparation).
•    Completing document control and change management activities.
•    Receiving/processing corporate Quality System and compliance documentation.
•    Maintaining databases/indecies as required by the Quality System.
•    Following regulatory requirements (QSR, CFR and ISO) and maintaining a wide variety of records.
•    Maintaining controlled documents so that files can be found by those searching for them easily and in a timely manner, in both paper and electronic format.        
•    Assigning control numbers as needed (i.e. ECN number, document number, part number, validation number, etc.).
•    Assisting in documentation research for various groups.
•    Any temporary assigned task or project, as needed, by the department manager.

Education / Experience Requirements

•    High School Diploma or GED equivalent required.
•    Knowledge of cGMP/GDP (Good Manufacturing Practices/Good Documentation Practices) required.
•    Minimum of 1 year working in document control, records, and information management strongly preferred OR minimum of 3 years of working in an ISO 13485/9001 manufacturing environment required. 
•    Record-Keeping experience preferred. 
•    Priority management experience required
•    Basic SAP system knowledge highly preferred 
•    Agile system experience preferred.
•    Proficient in Microsoft Excel, Word, Outlook required.
 

Specialized Skills / Other Requirements

•    Ability to read and understand quality system documents is required.
•    Must have high attention to detail and be highly organized.
•    Strong computer skills
•    Excellent verbal and written communication skills.
•    Must work well independently as well as in a team environment.  
•    Ability to assess and adjust to changing priorities and responsibilities.  
•    Ability to work overtime 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.


Nearest Major Market: Bellows Falls
Nearest Secondary Market: Keene