Quality Systems Engineer

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

Section

Details

Job Title

Quality Systems Engineer

Job Type

Full Time

Client Location

Irvine, CA

Work Arrangement

Onsite

Duration

Full Time

Pay Rate / Salary

$70-$80k/yr.

Job Summary

• A Quality Systems Engineer is responsible for developing, implementing, maintaining, and continuously improving quality management systems to ensure products, processes, and operations meet organizational, regulatory, and industry quality standards.
• The role works closely with engineering, manufacturing, operations, QA, suppliers, and compliance teams to drive quality improvements, reduce defects, and maintain audit readiness.

Key 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.

Required Qualifications

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