Quality Systems Engineer-4

REALIGN LLC; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

REALIGN LLC in Irvine, CA is seeking a detail‑oriented Quality Investigator to lead CAPA and Nonconformance investigations within a regulated medical device environment. You will manage containment, data collection, root cause analysis, and corrective actions to ensure timely closure.

Strong documentation, clear communication, and collaboration with cross‑functional teams are essential, as is experience with eQMS tools (ETQ preferred).

Qualifications

• Strong written and verbal communication skills.
• Experience in the medical device industry is a plus.
• Familiarity with CAPA and Nonconformance processes.
• Hands-on CAPA/NC investigations including containment, root cause, corrections, and actions.
• Ability to create clear, evidence-based investigation docs.

Responsibilities

• Execute and manage CAPA and NC investigations per procedures and QMS requirements.
• Lead investigations from initiation to closure, including containment, data collection, root cause analysis, corrections, and effectiveness planning.
• Apply problem-solving methods to determine causes and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users for evidence and actions.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.
• Ensure records are accurate, timely, and evidenced.
• Track milestones and maintain visibility of open actions for timely closure.
• Enter and maintain quality records in the eQMS; ETQ experience preferred.
• Support quality-system metrics, audits, and inspections.
• Identify opportunities to improve investigation quality and workflow.
• Perform other quality-system duties as assigned.

Skills

Written & verbal comms

CAPA & NC processes

Quality investigations

eQMS ETQ experience

Cross-functional coordination

Documentation & traceability

Detail-oriented

MS Office suite

Tools

ETQ eQMS

Job description

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

Roles & 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.