Document Control Clerk

Company: Medical Components, Inc.
Location: Harleysville
Posted on: March 19, 2023

Job Description:

This is a temporary position we are hoping will turn into a -permanent position. - It is still a 40+ hour a week job.Qualifications - - -High School Diploma but would prefer a bachelor's degree (B. A.) from four-year college or university; or two+ years related experience and/or training; or equivalent combination of education and experience.Prior knowledge of Document Control and/or Medical Devices is a plus.What you will be responsible for: - Compiling -and maintaining -controlled records and related files to release work orders, drawings, and engineering documents to manufacturing and other operating departments by performing the following duties.Essential Duties and Responsibilities include the following. Other duties may be assigned.Product Change Requests (CRs)
Obtain approvals.
Process the change(s) in PowerLink.
Scan completed CRs along with all supporting documentation to WebDocs.
File CRs, box previous years CRs to be kept in storage for the total retention period per QA-C-700-3.
Send Vendor Notification forms to vendors along with new and/or revised drawings or purchase material specifications.Send Vendor Notifications to MMW along with new and/or updated catalog codes. -Document Change Requests (DCRs)
Perform final check of document changes in Microsoft Office/Word and/or Excel.
Upload into Entropy for approval.
Once the document is approved and "Published" via Entropy, withdraw previous version. Move current copy from Signatures to Docctl.Move obsolete copy to the Obsolete Documents folder on the network.
Update 3-year review index.Update Master Document List.Update Document Change Summary.Update Applicable Documents Matrix.Update Status Report which lists current version number.Update Training Matrix. Instructions for Use
Create and/or revise Instructions for Use, using InDesign software.
Obtain quotes for translation of Instructions for Use.
Maintain IFU's on the network. Global Unique Device Identification Database (GUDID) / FDA Update and maintain the Medcomp GUDID database, which contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). Global Medical Device Nomenclature (GMDN)Update and maintain the Medcomp GMDN database, which is a list of generic names used to identify all medical device products. External Regulations and Standards
Maintain external regulations and standards via Compliance Navigator. If standards are not available through Compliance Navigator, order them through an alternate supplier. If purchasing standard from alternate supplier: Download new/revised standards to the network for easy access for all employees.
Scan hard copies of regulations/standards that cannot be downloaded from the supplier's website. Update the log when new or revised standards are obtained.Scan and upload workorders to WebDocs.

Keywords: Medical Components, Inc., Philadelphia , Document Control Clerk, Other , Harleysville, Pennsylvania