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.
Quality Systems Engineer • Irvine, CA, United States
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