Linux system engineer • irvine ca
Job Title: Quality Systems Engineer<br /> Location: Irvine, CA 92618 Onsite<br /> Duration: 12 Months<br /> Experience: 2 4 years, preferably in Medical Device</b><... Show more
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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.
