[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-258819-105":53,"doc-detail-258819-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","senior-quality-engineer-job-description","Senior Quality Engineer - Job Description","","Role requires an experienced candidate with proven background in quality and regulatory control for medical devices, working independently within a company-wide team to maintain high quality and performance standards. Reporting to the Senior Quality/Regulatory Manager, responsibilities span QA representation in design service projects, documentation development in line with FDA/ISO/MDD, validation protocol initiation (IQ/OQ/PQ), engineering change control, and customer complaint handling. Key duties also include CAPA leadership, nonconformance and root-cause analysis, risk analysis (FMEA), audits, regulatory support, and release/review of final product documentation.",{"@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/senior-quality-engineer-job-description/258819/",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/senior-quality-engineer-job-description/258819.png","ImageObject",442,249,{"name":88,"@type":89},"McQueen","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-21","2026-09-13",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 does the Senior Quality Engineer primarily do?","Question",{"text":108,"@type":109},"Act as the QA representative across design service projects, manage documentation control, support validation and engineering change activities, and handle quality investigations including nonconformance and root-cause analysis.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which standards and regulatory areas does the role emphasize?",{"text":113,"@type":109},"Documentation must comply with FDA, ISO, and MDD requirements, and the position supports audits involving notified bodies, regulatory agencies, customers, and internal/supplier audits.",{"name":115,"@type":106,"acceptedAnswer":116},"What qualifications are required for the Senior Quality Engineer?",{"text":117,"@type":109},"A degree in manufacturing engineering, quality engineering, life science or related field, plus a minimum of 5 years’ experience in the medical device industry, along with strong communication skills and team-based capability.","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},258819,1790345673,{"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},5909890329169,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Job Description:  SENIOR QUALITY ENGINEER  \nROLE  \nThe position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.  \nReporting to the Senior Quality / Regulatory Manager, the position will be challenging and will require an ability to work autonomously  \nPRINCIPLE RESPONSIBILITIES/DUTIES  \nThe Senior Quality Engineer will be principally engaged in the following tasks:  \n• Act as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.  \n• Develop and maintain documentation in compliance with FDA, ISO, MDD requirements  \n• Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)  \n• Initiate / Approve Engineering Change notices  \n• Process Customer Complaints and manage customer replies  \n• Actively participate in the Documentation control process  \n• Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations  \n• Participate / Lead Risk Analysis initiatives e.g. FMEA  \n• Initiate / Approve Reworks  \n• Initiate / Support implementation of effective Corrective / Preventive Actions  \n• Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.  \n• Represent QA as part of the Material Review Board  \n• Perform Internal and Supplier Audits  \n• Support Notified Body / Regulatory Agency / Customer Audits  \n• Review / Approve / Release final product documentation  \n• Support the Environmental monitoring process  \n• Support activities associated with Sterilization  \n• Act as the QA representative for Supplier Quality management activities  \n• Collate and trend Key performance indicator data  \n• Actively participate in Management Review & Compliance meetings  \n• Act as delegate for Quality Manager when required  \n• Performs other related duties, as assigned  \nROLE REQUIREMENTS  \n• A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 5 yrs. experience within the Medical Device Industry.  \n• Candidate must be highly motivated with excellent communication skills and proven ability to work as part ofa team.  \n• Experience of using Lean Manufacturing Tools and Techniques an advantage  \n• Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.","cbCaiof8FlgI3zjt","https://ap.wps.com/l/cbCaiof8FlgI3zjt","pdf",92082,"English","# Role\n## Principle Responsibilities/Duties\n## Role Requirements","[{\"question\":\"What does the Senior Quality Engineer primarily do?\",\"answer\":\"Act as the QA representative across design service projects, manage documentation control, support validation and engineering change activities, and handle quality investigations including nonconformance and root-cause analysis.\"},{\"question\":\"Which standards and regulatory areas does the role emphasize?\",\"answer\":\"Documentation must comply with FDA, ISO, and MDD requirements, and the position supports audits involving notified bodies, regulatory agencies, customers, and internal/supplier audits.\"},{\"question\":\"What qualifications are required for the Senior Quality Engineer?\",\"answer\":\"A degree in manufacturing engineering, quality engineering, life science or related field, plus a minimum of 5 years’ experience in the medical device industry, along with strong communication skills and team-based capability.\"}]","Senior Quality Engineer - Job Description | PDF",1789326192]