{"schemaVersion":"jobsearcher.job.v1","id":"440be0d24c2aea00a27cc26a","url":"https://jobsearcher.com/jobs/440be0d24c2aea00a27cc26a","canonicalUrl":"https://jobsearcher.com/jobs/440be0d24c2aea00a27cc26a","title":"Senior Quality Engineer","description":"OverviewIn this role you support the quality framework for medical devices by ensuring investigations and regulatory-compliant processes. You will handle complaint reviews, SOP updates, and lab activities aligned with regulatory standards. You will apply analytical methods and support audits, contributing to the lab's quality objectives. This telecommuting position enables you to impact patient safety while collaborating with the global quality team at embecta.ResponsibilitiesLead and ensure compliance of product complaint investigations with FDA QSR, ISO 13485, and related directivesReview and validate customer complaints for proper processing and investigation per corporate proceduresUpdate and enforce SOPs, equipment maintenance, hazmat and biohazard disposal protocols for the labPerform FTIR analysis and other qualitative/quantitative analyses to identify materials and investigate foreign matterProgram mechanical lab equipment (e.g., Chatillon) and analyze generated dataProvide audit support, including preparation and facilitation of lab toursSupport CAPA processes and engineering design change management for medical devicesKey requirementsMaster's degree in Engineering (any) with 3 years of relevant experience, or Bachelor's degree with 5 years of relevant experienceExperience with regulatory and international standards including 21 CFR 820, ISO 13485, ISO 14971Statistics for trend analysis and complaint data evaluationProficiency in Quality Engineering tools: Root Cause Analysis, Design of Experiments, Statistical AnalysisExperience with internal and external quality audits and QMS representation during external auditsCAPA investigation, root cause analysis, and corrective actionsEngineering Design Change Management and DHF management for medical devicesAnalytical thinkingDetail-orientedCollaborative cross-functional communicationFTIR analysisQuality systems regulation (FDA QSR)Statistical analysis","company":"Embecta","rawCompany":"embecta","city":"Washington","state":"DC","isRemote":false,"isActive":false,"createdAt":"2026-10-26T13:11:40.055Z","occupations":[{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality Engineer","description":"OverviewIn this role you support the quality framework for medical devices by ensuring investigations and regulatory-compliant processes. You will handle complaint reviews, SOP updates, and lab activities aligned with regulatory standards. You will apply analytical methods and support audits, contributing to the lab's quality objectives. This telecommuting position enables you to impact patient safety while collaborating with the global quality team at embecta.ResponsibilitiesLead and ensure compliance of product complaint investigations with FDA QSR, ISO 13485, and related directivesReview and validate customer complaints for proper processing and investigation per corporate proceduresUpdate and enforce SOPs, equipment maintenance, hazmat and biohazard disposal protocols for the labPerform FTIR analysis and other qualitative/quantitative analyses to identify materials and investigate foreign matterProgram mechanical lab equipment (e.g., Chatillon) and analyze generated dataProvide audit support, including preparation and facilitation of lab toursSupport CAPA processes and engineering design change management for medical devicesKey requirementsMaster's degree in Engineering (any) with 3 years of relevant experience, or Bachelor's degree with 5 years of relevant experienceExperience with regulatory and international standards including 21 CFR 820, ISO 13485, ISO 14971Statistics for trend analysis and complaint data evaluationProficiency in Quality Engineering tools: Root Cause Analysis, Design of Experiments, Statistical AnalysisExperience with internal and external quality audits and QMS representation during external auditsCAPA investigation, root cause analysis, and corrective actionsEngineering Design Change Management and DHF management for medical devicesAnalytical thinkingDetail-orientedCollaborative cross-functional communicationFTIR analysisQuality systems regulation (FDA QSR)Statistical analysis","datePosted":"2026-10-26T13:11:40.055Z","dateModified":"2026-10-26T13:11:40.055Z","hiringOrganization":{"@type":"Organization","name":"Embecta","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Washington","addressRegion":"DC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"440be0d24c2aea00a27cc26a"},"url":"https://jobsearcher.com/jobs/440be0d24c2aea00a27cc26a"}}