{"schemaVersion":"jobsearcher.job.v1","id":"4a4b4ffc48562705b4e93bf1","url":"https://jobsearcher.com/jobs/4a4b4ffc48562705b4e93bf1","canonicalUrl":"https://jobsearcher.com/jobs/4a4b4ffc48562705b4e93bf1","title":"Quality Systems Engineer","description":"Strong written and verbal communication skills, with the ability to clearly document and present investigation outcomes.\n\nPrevious experience in the medical device industry; prior experience is a plus .\n\nWorking knowledge of Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes.\n\nHands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions.\n\nAbility to develop clear, objective, and evidence-based investigation documentation that is complete, traceable, and inspection-ready.\n\nStrong organizational and follow-up skills to coordinate day-to-day activities, action items, timelines, and meetings with system users and cross-functional stakeholders.\n\nAbility to prioritize multiple investigations and quality-system deliverables while maintaining attention to detail.\n\nExperience using an electronic Quality Management System (eQMS); ETQ experience is preferred.\n\nProficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.\n\nExecute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements.\n\nLead investigation activities from initiation through closure, including containment, issue bounding, data collection, root cause analysis, corrections, corrective actions, and effectiveness planning, as applicable.\n\nApply structured problem-solving and root cause analysis methods to determine the cause of quality issues and support risk-based decisions.\n\nCoordinate with investigation owners, process owners, subject-matter experts, and other cross-functional users to obtain objective evidence and complete assigned actions.\n\nFacilitate routine investigation follow-up meetings, document decisions and action items, and proactively communicate risks, delays, and escalations.\n\nEnsure investigation records are accurate, clear, complete, timely, and supported by appropriate evidence and rationale.\n\nTrack CAPA, NC, and investigation milestones; maintain visibility of open actions and support timely closure.\n\nEnter, update, route, and maintain quality records in the applicable eQMS; experience with ETQ is preferred.\n\nSupport quality-system metrics, trend reviews, internal audits, and regulatory or customer inspection readiness, as assigned.\n\nIdentify opportunities to improve investigation quality, workflow efficiency, and user compliance with established procedures.\n\nPerform other quality-system duties as assigned.\n\n#J-18808-Ljbffr","company":"Q1 Technologies","rawCompany":"q1 technologies","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-09-17T03:15:23.636Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Systems Engineer","description":"Strong written and verbal communication skills, with the ability to clearly document and present investigation outcomes.\n\nPrevious experience in the medical device industry; prior experience is a plus .\n\nWorking knowledge of Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes.\n\nHands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions.\n\nAbility to develop clear, objective, and evidence-based investigation documentation that is complete, traceable, and inspection-ready.\n\nStrong organizational and follow-up skills to coordinate day-to-day activities, action items, timelines, and meetings with system users and cross-functional stakeholders.\n\nAbility to prioritize multiple investigations and quality-system deliverables while maintaining attention to detail.\n\nExperience using an electronic Quality Management System (eQMS); ETQ experience is preferred.\n\nProficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.\n\nExecute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements.\n\nLead investigation activities from initiation through closure, including containment, issue bounding, data collection, root cause analysis, corrections, corrective actions, and effectiveness planning, as applicable.\n\nApply structured problem-solving and root cause analysis methods to determine the cause of quality issues and support risk-based decisions.\n\nCoordinate with investigation owners, process owners, subject-matter experts, and other cross-functional users to obtain objective evidence and complete assigned actions.\n\nFacilitate routine investigation follow-up meetings, document decisions and action items, and proactively communicate risks, delays, and escalations.\n\nEnsure investigation records are accurate, clear, complete, timely, and supported by appropriate evidence and rationale.\n\nTrack CAPA, NC, and investigation milestones; maintain visibility of open actions and support timely closure.\n\nEnter, update, route, and maintain quality records in the applicable eQMS; experience with ETQ is preferred.\n\nSupport quality-system metrics, trend reviews, internal audits, and regulatory or customer inspection readiness, as assigned.\n\nIdentify opportunities to improve investigation quality, workflow efficiency, and user compliance with established procedures.\n\nPerform other quality-system duties as assigned.\n\n#J-18808-Ljbffr","datePosted":"2026-09-17T03:15:23.636Z","dateModified":"2026-09-17T03:15:23.636Z","hiringOrganization":{"@type":"Organization","name":"Q1 Technologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4a4b4ffc48562705b4e93bf1"},"url":"https://jobsearcher.com/jobs/4a4b4ffc48562705b4e93bf1"}}