Quality Systems Engineer

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