Quality Systems Engineer — Onsite Medical Devices CAPA Lead

Siri InfoSolutions Inc; Irvine (CA); On-site; USD 70,000 - 80,000; Full time

Job summary

Siri InfoSolutions Inc in Irvine, CA is seeking a Quality Systems Engineer to develop, implement, and maintain quality-management processes to ensure compliance with regulatory standards.

You will lead CAPA investigations, manage nonconformances, perform root‑cause analysis, and coordinate cross‑functional teams to drive continuous improvement and audit readiness. The role requires hands‑on eQMS experience (ETQ preferred) and strong documentation skills; onsite work near Irvine, CA.

Qualifications

• Experience in quality systems and regulatory requirements.
• Strong CAPA and nonconformance processes experience.
• Ability to document investigations clearly and traceably.

Responsibilities

• Execute and manage CAPA and nonconformance investigations.
• Lead investigations from initiation to closure with containment and RCA.
• Apply problem-solving methods to determine root causes and corrective actions.
• Coordinate with owners and cross-functional teams for evidence and actions.
• Facilitate follow-up meetings and maintain action transparency.

Skills

Quality systems

CAPA

Nonconformance

Root cause analysis

Documentation

Project coordination

Microsoft Word

Tools

ETQ

eQMS

Microsoft Word

Excel

PowerPoint

Outlook

Teams

Job description

Siri InfoSolutions Inc in Irvine, CA is seeking a Quality Systems Engineer to develop, implement, and maintain quality-management processes to ensure compliance with regulatory standards.

You will lead CAPA investigations, manage nonconformances, perform root‑cause analysis, and coordinate cross‑functional teams to drive continuous improvement and audit readiness. The role requires hands‑on eQMS experience (ETQ preferred) and strong documentation skills; onsite work near Irvine, CA.