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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.

Quality Records
Provide all departments with labels for the contents of their boxes to be kept in storage.
At least yearly box work orders for storage.
At least yearly box CRs for storage.
Maintain the Record Storage Log on the network.
Communicate with shipping personnel to retrieve archived documents from the warehouse, when necessary.
-About Us - Medcomp - develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies. Our offerings have our Team Members well-being in mind.
Hybrid working environment, but could be fully remote for the right candidateCompetitive compensationHealth, Dental, Vision coverageFSALife Insurance401kPaid HolidaysGenerous PTOWhat you will get from us:VISION & MISSION STATEMENTTo be the leading solution provider for every customer we serve.To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed. We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.Powered by JazzHR

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

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