Quality Systems Engineer

Job overview

The Quality Systems Engineer works onsite in Irvine, CA. Compensation is not specified. The role supports quality-system activities in a regulated medical-device environment. The engineer manages CAPA and nonconformance investigations from initiation through closure, using evidence-based analysis and documentation. This work supports compliant quality systems and inspection-ready records while coordinating actions across stakeholders.

What you'll do

• Manage CAPA and nonconformance investigations
• lead investigations through containment, issue definition, data collection, root-cause analysis, corrections, corrective actions, and effectiveness planning where applicable
• support risk-based decisions
• coordinate with investigation and process owners and subject-matter experts
• facilitate follow-up meetings and document decisions and actions
• communicate status, delays, risks, and escalations
• maintain accurate, complete, timely, traceable investigation records
• track milestones and open actions
• maintain records in the electronic Quality Management System
• support inspection-ready documentation and compliance with procedures and regulations.

What we're looking for

Skills & competencies

quality systems engineer

medical device

irvine ca

capa

nonconformance investigations

root-cause analysis

corrective actions

eqms

quality documentation

regulatory compliance

Work arrangement

• Weekend coverage required

Why this role

Medical-device industry experience and hands-on CAPA, nonconformance, and quality-investigation experience required; bachelor’s degree in engineering, life sciences, or a related technical discipline listed.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.