Job Description

This is a remote position. Duties: · Learn Division of Engineering tools and expectations. · Document controls system (SolidWorks PDM) structure, navigation, and use. · Engineering change order process. · Document templates. · Assist with document revisions from annual review. For each document: · Accept redlines from document owner (facilitate review?). · Review documents and suggest further incremental improvements. · Verify reference documents section. · Documents referenced in text are included in reference section. · Documents in reference section exist. · Documents in reference section have correct part number referenced. · Identify and suggest changes needed for FDA QMSR (IS-13485 adoption). · Identify and suggest changes to other documents needed to align with changes to subject document. · Coordinate final review of redlined/revised document. · Accept changes to generate clean copy. · Submit document for approval. · Assist in creating a Preventive Maintenance (PM) database in Intelex for all the Shop equipment and AMF equipment. · Coordinate with the Shop and AMF personnel t-create a master list of equipment t-be on PM. · Create a PM schedule and input all the equipment into the Intelex maintenance module with inputs from Shop and AMF personnel. · Assist in implementing the improvements to the QMS documents noted in the QMS Continuous Improvements Record. · Review the Continuous Improvement Record and facilitate review of the noted documents. · Coordinate final review of redlined/revised document. · Accept changes to generate clean copy. · Submit document for approval. · Perform EPDM Folder Review. · Review the revision status of all the Quality Systems Regulations (QSR) documents. · Documents with status as under revision or under review (A.xx, e.g.) shall be investigated to determine the steps needed to complete the revision with the help of the QE or document owner. · Documents with revision noted as Preliminary documents (Pm. xx) shall be investigated to determine if they need t-be released or if they should remain archived with the help of the QE or document owner. · Identify and repair documents with broken PDM macros. · Complete the actions from the above steps and submit the documents for approval or archive them. · Other Duties: · Assist in creating simple forms/templates for the QSR.   Skills: · See education section for required experience. · Strong writing skills with good grammar. · Attention to detail. · Able to work on multiple documents in parallel. · Able to create simple forms and templates. · Nice to have: Knowledge of FDA Quality System Regulation, Quality Management System Regulation, and IS-13485. · The employee needs to be able to use MS Office tools and interact with our solid works PDM document system. · They need to have good enough written English language skills to incorporate redline document changes sensibly.   Preferred Skills & Experience: Ability to do some original writing.   Education: · An A.A. in Business or English (or related) with four (4) years of experience. · OR Bachelor of Arts degree.   Notes: The employee needs to be able to use MS Office tools and interact with our Solidworks PDM document system. They need to have good enough written English language skills to incorporate redline document changes sensibly. Ability to do some original writing would be a plus. An A.A. in Business or English (or related) with 4 years’ experience or a B.A..

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