Quality System Engineer

Job Title: Quality Systems Engineer
Location: Irvine, CA 92618 Onsite
Duration: 12 Months
Experience: 2 4 years, preferably in Medical Device

Education: Bachelor's degree in Engineering, Life Sciences, Quality, or related field

Must-Have Skills:

Quality Systems experience within the medical device industry

Strong CAPA and Nonconformance (NC) investigation experience

Experience with quality investigations, including:

Containment

Issue/problem definition

Data collection

Root Cause Analysis

Corrective/Preventive Actions

Effectiveness checks

Experience developing clear, objective, evidence-based investigation documentation

Ability to coordinate investigations with cross-functional teams and stakeholders

Experience tracking CAPA, NC, action items, and investigation milestones

Knowledge of Quality Management Systems (QMS)

ETQ experience preferred

Strong communication, organization, follow-up, and meeting facilitation skills

Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams

Key Responsibilities:

Manage CAPA and Nonconformance investigations from initiation through closure.

Lead investigations involving containment, issue definition, root cause analysis, corrective actions, and effectiveness checks.

Review evidence and provide risk-based recommendations.

Coordinate with process owners, investigation owners, SMEs, and cross-functional stakeholders.

Conduct investigation follow-up meetings and track action items.

Maintain accurate investigation records and ensure timely closure.

Track CAPA/NC milestones and maintain quality records in applicable QMS.

Support quality-system metrics, trend investigations, internal audits, and regulatory compliance.

Identify opportunities to improve investigation quality, workflow efficiency, and compliance.