[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-263425-105":53,"doc-detail-263425-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","director-of-quality-assurance-job-description","Director of Quality Assurance - Job Description","","Job description for the Director of Quality Assurance at Wishbone Medical Inc, reporting to the Chief Technology Officer. The role manages the Quality Management System (QMS) and ensures compliance with current and future U.S. FDA, ISO, and medical device MDR standards, including sterile packaging. Responsibilities span QMS ownership, design quality oversight, CAPA, audits, post-market surveillance, device complaint investigations, and global quality system strategy, alongside budgeting, documentation approvals, and training compliance across virtual manufacturing and contract manufacturing subsidiaries.",{"@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":16,"@type":70,"position":76},"https://docshare.wps.com/template/resumes/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/director-of-quality-assurance-job-description/263425/",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/director-of-quality-assurance-job-description/263425.png","ImageObject",442,249,{"name":88,"@type":89},"Logic","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-15","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 is the primary responsibility of the Director of Quality Assurance?","Question",{"text":108,"@type":109},"To manage the full Quality Assurance function by owning and maintaining Wishbone Medical’s Quality Management System (QMS) and ensuring compliance with applicable medical device regulations and standards.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which regulatory areas does the role cover?",{"text":113,"@type":109},"The role focuses on compliance with current and future U.S. FDA requirements, ISO standards, and MDR standards/regulations for medical devices, including requirements related to sterile packaging.",{"name":115,"@type":106,"acceptedAnswer":116},"What duties are included in post-market and audit activities?",{"text":117,"@type":109},"The director leads post-market surveillance, including complaint investigations and field actions, and serves as the point of contact for FDA or authorized authority QMS/product audits, directing internal and external audit planning and execution.","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},263425,1790198964,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":15,"category_name":16,"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":139,"read_time":9},1099513958762,"https://ap-avatar.wpscdn.com/avatar/1000023916a998db790?x-image-process=image/resize,m_fixed,w_180,h_180&k=1784791008015729253","JOB DESCRIPTION  \n\n| JOB TITLE: DIRECTOR OF QUALITY ASSURANCE |  |\n| --- | --- |\n| BUSINESS DIVISION: WISHBONE MEDICAL INC | STATUS: SALARY/EXEMPT |\n| DEPARTMENT NAME: QUALITY & REGULATORY | TYPE: FULL-TIME |\n| PREPARED BY: HUMAN RESOURCES | DATE: 1/11/2022 |\n| WORK LOCATION: CORP-WARSAW | REPORTS TO: CHIEF TECHNOLOGY OFFICER |\n\nSUMMARY:  \nThe Director of Quality Assurance is responsible for managing all facets of quality assurance, including ownership of the Quality Management System for Wishbone Medical. The primary focus is to ensure that the Quality Management System (QMS) and all aspects of quality assurance are compliant to current and future U.S. FDA, ISO, and MDR Standards and Regulation for Medical Devices, including sterile packaging for WishBone products. As WishBone Medical is a virtual manufacturer, this position also provides guidance for quality activities at the Red Star Contract Manufacturing and Response Ortho subsidiaries.  \nESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties maybe assigned)  \n􀁸 Ensures the QMS and design quality requirements are effectively established and maintained in accordance with medical device regulations and international standards  \n􀁸 Responsible for business processes that ensure conformance of the device with the QMS prior to release and for post-market surveillance  \n􀁸 Responsible for management of the Design Quality Engineers as well as oversight and prioritization of departmental tasks and projects  \n􀁸 Develops systems, implements, and trains employees on quality and regulatory requirements including, but not limited to, corrective and preventative actions (CAPA), quality audits, post market surveillance and vigilance, andrecalls and removals  \n􀁸 Manages systems for design, development, verification, validation, distribution, storage, tracking, post-market surveillance, and retrieval of information pertinent to the design quality processes  \n􀁸 Supports product development teams to help meet their objectives  \n􀁸 Oversees quality metrics and quality initiatives, including responsibility for quarterly and annual internal reporting  \n􀁸 Leads and manages post-market surveillance, including device investigations for complaints and field actions  \n􀁸 Develops and facilitates a strategy for a single global quality system and maintains a quality-focused culture  \n􀁸 Manages and ensures compliance to training requirements  \n􀁸 Point of contact and lead for all announced and un-announced QMS and product audits from the FDA or authorized regulatory authorities  \n􀁸 Directs the planning and execution of all internal and external audits  \n􀁸 Develops and maintains the quality department budget  \n􀁸 Reviews and approves document changes for Quality Assurance, as required  \nQUALIFICATION REQUIEMENTS:  \n􀁸 Bachelor’s degree, or equivalent, is required  \n􀁸 7-10 years of experience in Quality Assurance or Design Quality Engineering  \n􀁸 A minimum of 3 years’ experience in medical device  \n􀁸 A minimum of 3 years’ experience in a management role with direct reports is required  \n􀁸 A combination of education, experience, leadership, strategy, and QA/RA influence may be considered  \n􀁸 Experience in design quality engineering, measurement system analysis, and design verification and validation testing is preferred  \n􀁸 Working knowledge of Design Controls Process and Quality System Regulations for Medical Devices  \nOTHER SKILLS and ABILITIES:  \n􀁸 Strong interpersonal, organizational, problem-solving, and analytical skills with a strong attention to detail  \n􀁸 Demonstrated strong writing and communication skills and ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports  \n􀁸 Ability to manage competing priorities and ability to manage projects of various sizes and constitutions  \n􀁸 Management of personnel  \n􀁸 Versatility, flexibility, and willingness to work with changing priorities  \n􀁸 Advanced knowledge of ove","cbCain0E41qaK1Ib","https://ap.wps.com/l/cbCain0E41qaK1Ib","pdf",132920,"English","# Job Title\n## Summary\n## Essential Duties and Responsibilities\n## Qualification Requirements\n## Other Skills and Abilities\n## Physical Demands\n## Work Environment","[{\"question\":\"What is the primary responsibility of the Director of Quality Assurance?\",\"answer\":\"To manage the full Quality Assurance function by owning and maintaining Wishbone Medical’s Quality Management System (QMS) and ensuring compliance with applicable medical device regulations and standards.\"},{\"question\":\"Which regulatory areas does the role cover?\",\"answer\":\"The role focuses on compliance with current and future U.S. FDA requirements, ISO standards, and MDR standards/regulations for medical devices, including requirements related to sterile packaging.\"},{\"question\":\"What duties are included in post-market and audit activities?\",\"answer\":\"The director leads post-market surveillance, including complaint investigations and field actions, and serves as the point of contact for FDA or authorized authority QMS/product audits, directing internal and external audit planning and execution.\"}]","Director of Quality Assurance - Job Description | PDF",1789370898]