Documentation Control Specialist
Teleflex

Job Order #: 17624309

Chelmsford, MA 01824

Full Time

40 hours per week

POSTED 9/6/2022

EXPIRES 12/5/2022

Job Description

POSITION SUMMARY:
The Documentation Control Specialist is responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the lifecycle of products and ensuring conformance to applicable MDR, QS and other applicable requirements. This position will evaluate and process electronic change orders for completeness and adherence to procedures and will ensure appropriate distribution and notification.

PRINCIPAL RESPONSIBILITIES:
-    Subject matter expert in change control as it relates to product lifecycle
-    Facilitate the timely change, approval, and release of product documentation and data (PLM, ERP)
-    Maintain new Item Master set-up and other related data in applicable ERP
-    Prepare Quality records for electronic scanning and off-site archiving; administer the system for archiving and off-site storage of document control and data records in accordance with defined requirements
-    Generate, assign, update, and ensure accuracy of the Global Trade Identification Number (GTIN) information in the Data Sync Direct
-    Partner with Regulatory and Packaging/Labeling teams to oversee and manage IFU-to-Web process and ensuring MDR regulatory requirements are met and maintained
-    Support development of new product documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives
-    Provide inventory control and maintenance of the central document reference library, including standards and guidelines
-    Assist in monitoring process effectiveness, including the impact of changes, and recommend process improvements
-    Utilize visual management and participate in problem solving, metric reporting/improvement, and other various projects, as assigned
-    Apply best practices in change control, configuration management, and continuous improvements
-    Provide high-level customer service and support to specific cross-functional areas
-    Participate in and/or lead special projects, as assigned
-    Provide audit and training support, as requested

EDUCATION / EXPERIENCE REQUIREMENTS:
-    Bachelor?s Degree preferred
-    The successful candidate will have a minimum of three years relevant experience and a high level knowledge of quality systems, compliance and change control requirements in a regulated industry.
-    Broad functional expertise in change control management

POSITION DESCRIPTION
-    Ability to effectively execute projects and related activities with appropriate priority required
-    Excellent critical thinking skills & ability to identify and solve problems of moderate scope & complexity
-    Ability to function as part of a team and achieve results through open collaboration with others
-    Results oriented with the ability to be accountable to the achievement of both individual and team goals

PHYSICAL & ENVIRONMENTAL REQUIREMENTS:
-    Ability to sit, stand, walk throughout the day as needed in an office and light manufacturing/assembly environment to perform tasks
-    Fine and gross motor skills to perform tasks using standard office equipment including frequent keyboarding, computers, peripherals, phones, and other devices as required
-    Ability to communicate clearly both in writing and using spoken communication, with or without assistance
-    Ability to read, comprehend, and appropriately act upon detailed written information at an advanced level, with or without assistance
-    Infrequent lifting of up to 20 pounds may be required

How To Apply

Please email your resume to thavrith.thao@masshirelowellcc.com for consideration

Address

16 Elizabeth DRIVE
Chelmsford, MA 01824

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Shift

First

Not Specified

Per Diem Position

Not Specified

Union Position

No

Apprenticeship

No

Pay

Not Specified

Benefits

  • Benefits Unknown

Benefit Details

Name

Thavrith Thao

Title

Business Services Representative

Email

thavrith.thao@masshirelowellcc.com

Phone

978-805-4875

Address

107 Merrimack Street
Lowell, MA 01852

Website

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