Quality Systems Engineer-5

REALIGN LLC; Irvine (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

REALIGN LLC in Irvine, CA seeks a CAPA/NC Investigator to lead quality investigations within the medical device quality system. You will drive containment, root-cause analysis, corrections, and preventive actions, ensuring evidence-based, traceable documentation.

You will coordinate with cross-functional teams, maintain timely records, and support regulatory or customer inspections with rigorous adherence to procedures and traceability.

Qualifications

• Strong written and verbal communication skills; ability to document and present investigation outcomes clearly.
• Experience in the medical device industry; prior experience is a plus.
• Working knowledge of CAPA and Nonconformance (NC) processes.
• Hands-on experience managing quality investigations: containment, issue bounding, RCA, corrections, and actions.
• Clear, objective investigation documentation that is traceable and inspection-ready.

Responsibilities

• Execute and manage CAPA and NC investigations per procedures and quality-system requirements.
• Lead investigation activities from initiation to closure, including containment and corrective actions.
• Apply structured problem-solving and RCA to determine root causes and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users for objective evidence.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.

Skills

Communication skills

CAPA/NC processes

Quality investigation management

Evidence-based documentation

Cross-functional coordination

Experience in medical device industry

eQMS/ETQ familiarity

MS Office proficiency

Tools

ETQ eQMS

Microsoft Office Suite

Job description

Required Skills

• 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.