Quality Systems Engineer

Irvine, California 92602 Posted September 9th, 2026 Job Type: Full Time Job Category: IT Job Description Role: Quality Systems Engineer Location: Irvine, CA (Onsite) Fulltime – Permanent Job Description Must Have Technical/Functional Skills • Strong written and verbal communication skills, with the ability to clearly document and present investigation outcomes. • Previous experience in the medical device industry; prior experience is a plus. • Working knowledge of Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes. • Hands-on experience managing quality investigations, including immediate containment, issue bounding, root cause analysis, corrections, and corrective actions. • Ability to develop clear, objective, and evidence-based investigation documentation that is complete, traceable, and inspection-ready. • Strong organizational and follow-up skills to coordinate day-to-day activities, action items, timelines, and meetings with system users and cross-functional stakeholders. • Ability to prioritize multiple investigations and quality-system deliverables while maintaining attention to detail. • Experience using an electronic Quality Management System (eQMS); ETQ experience is preferred. • Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams. · Roles & Responsibilities • Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality-system requirements. • Lead investigation activities from initiation through closure, including containment, issue bounding, data collection, root cause analysis, corrections, corrective actions, and effectiveness planning, as applicable. • Apply structured problem-solving and root cause analysis methods to determine the cause of quality issues and support risk-based decisions. • Coordinate with investigation owners, process owners, subject-matter experts, and other cross-functional users to obtain objective evidence and complete assigned actions. • Facilitate routine investigation follow-up meetings, document decisions and action items, and proactively communicate risks, delays, and escalations. • Ensure investigation records are accurate, clear, complete, timely, and supported by appropriate evidence and rationale. • Track CAPA, NC, and investigation milestones; maintain visibility of open actions and support timely closure. • Enter, update, route, and maintain quality records in the applicable eQMS; experience with ETQ is preferred. • Support quality-system metrics, trend reviews, internal audits, and regulatory or customer inspection readiness, as assigned. • Identify opportunities to improve investigation quality, workflow efficiency, and user compliance with established procedures. • Perform other quality-system duties as assigned. Required Skills DevOps Engineer