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Responsibilities center on compliant routing and documentation accuracy, maintaining document control system integrity, controlling masters and records, and ensuring quality systems files align with ISO 13485, FDA 21 CFR Part 820 and 21 CFR Part 11, and applicable EU medical device regulations. Includes support for audits, internal audit execution, controlled standards library updates, ERP data inputs (SAP), and licensing/tissue state administration.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/job-description-quality-system-document-control-specialist/263308/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/job-description-quality-system-document-control-specialist/263308.png","ImageObject",442,249,{"name":88,"@type":89},"Lucas Martin","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-20","2026-09-14",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What are the core document control responsibilities for this role?","Question",{"text":108,"@type":109},"The role ensures accurate, timely routing of supporting documentation, maintains document control system integrity, and can authorize access denial or document creation, replacement, revision, or obsolescence. It also verifies work instructions, SOPs, quality reference documents, forms, and other documentation against specifications when possible.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which regulations and standards must the Quality System / Document Control Specialist comply with?",{"text":113,"@type":109},"The position requires maintaining documentation files in compliance with ISO 13485 and FDA 21 CFR 820 and 21 CFR Part 11, as well as EU medical device regulations including 93/42/EEC and EU MDR/2017.",{"name":115,"@type":106,"acceptedAnswer":116},"What qualifications and experience are required?",{"text":117,"@type":109},"The role requires strong multitasking, organization, communication, and problem-solving skills, along with detailed and accurate data entry. It also requires knowledge of 21 CFR 820 and ISO 13485 and experience in a regulated industry, preferably ISO 13485, with 1–2 years of related experience.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},263308,1789369258,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":9},8796095360427,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Choice Spine  \nJob Description  \nJob Title: Quality System / Document Control Specialist  \nDepartment: Regulatory Affairs  \nLocation: Knoxville, TN.  \nReports To: Director of Regulatory Affairs  \nShift: 1st  \nFLSA Status: Non-Exempt  \nPrepared By: Kim Finch  \nKNOWLEDGE/SKILLS REQUIRED:  \nJob Responsibilities:  \n● Ensures compliance and timeliness, accuracy of routing and supporting documentation to specifications. Authorized to correct as necessary.  \n● Maintains the integrity of the document control system. Authorized to deny access and to include, replace, revise or make obsolete documents therein. Has the responsibility to confirm the accuracy of Work Instructions, Standard Operating Procedures, Quality Reference Documents, forms and other documents against specifications whenever possible.  \n● Maintains the documentation files in compliance with ISO 13485. FDA 21CFR 820 and 21 CFR Part 11, EU Medical Device Regulations 93/42/EEC, and EU MDR/2017 .  \n● Responsible for the formal Quality Systems files to include company DHR’s,  \nDMR’s and DHF’s. Responds promptly, whenever possible to requests for information specific to the quality system documents.  \n● Creates, maintains, and improves controls on all documentation masters, device history records, change orders, design history files both manual and electronic archive.  \n● Maintains and updates the Standards Library.  \n● Interacts effectively with FDA and ISO Registrars and customers prior to and during audits concerning document  \n● Inputs data to create and revise material master / GUDID and Euamed database in the ERP system (SAP) .  \n● Performs internal audits as assigned.  \n● Maintains Tissue State Tissue Licenses  \n● Maintains Board of Pharmacy Licenses  \nSupervisory Responsibility: N/A  \nQualifications:  \n● Must have multi-task abilities, self-motivator and solid organizational skills.  \n● Knowledgeable in 21 CFR 820 and ISO 13485, and medical device regulations  \n● Experience working in a regulated industry, preferably ISO 13485.  \n● Good Communication Skills.  \n● Demonstrated problem solving skills.  \n● Working knowledge of desktop computer software, database software, scanning software and email applications.  \n● Must be very detail oriented and accurate with data entry.  \nEducation and/ or Experience:  \n● 1-2 years related experience in a regulated field required.  \nSignatory Responsibilities Documentation as needed.","cbCaihmDqfHrBUxG","https://ap.wps.com/l/cbCaihmDqfHrBUxG","pdf",93230,"English","# Job Responsibilities\n## Compliance & Document Control System\n## Quality Systems Documentation & Audits\n## Data Maintenance & ERP Inputs\n## Licenses & Recordkeeping\n# Qualifications\n## Skills & Knowledge Requirements\n## Education & Experience","[{\"question\":\"What are the core document control responsibilities for this role?\",\"answer\":\"The role ensures accurate, timely routing of supporting documentation, maintains document control system integrity, and can authorize access denial or document creation, replacement, revision, or obsolescence. It also verifies work instructions, SOPs, quality reference documents, forms, and other documentation against specifications when possible.\"},{\"question\":\"Which regulations and standards must the Quality System / Document Control Specialist comply with?\",\"answer\":\"The position requires maintaining documentation files in compliance with ISO 13485 and FDA 21 CFR 820 and 21 CFR Part 11, as well as EU medical device regulations including 93/42/EEC and EU MDR/2017.\"},{\"question\":\"What qualifications and experience are required?\",\"answer\":\"The role requires strong multitasking, organization, communication, and problem-solving skills, along with detailed and accurate data entry. It also requires knowledge of 21 CFR 820 and ISO 13485 and experience in a regulated industry, preferably ISO 13485, with 1–2 years of related experience.\"}]","Job Description - Quality System / Document Control Specialist | PDF"]