Quality Systems Engineer

REALIGN LLC; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

REALIGN LLC is seeking a quality investigations professional to lead CAPA and Nonconformance efforts within a medical device context. You will drive containment, data collection, root cause analysis, and corrective actions, while ensuring records are complete and traceable.

You will coordinate with process owners and subject-matter experts, maintain action timelines, and support regulatory or customer inspections. Strong documentation and office software skills are essential.

Qualifications

• Strong written and verbal communication skills for documenting and presenting investigation outcomes.
• Experience in the medical device industry is a plus.
• Working knowledge of CAPA and NC processes.
• Hands-on experience managing quality investigations including containment and corrective actions.
• Ability to develop objective, traceable, evidence-based investigation documentation.
• Strong organizational and follow-up skills for coordinating actions and timelines.
• Ability to prioritize multiple investigations while maintaining attention to detail.
• Experience using an eQMS; ETQ experience preferred.
• Proficiency with Word, Excel, PowerPoint, Outlook and Teams.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures and quality-system requirements.
• Lead investigations from initiation to closure, including containment, data collection, root cause analysis, and corrective actions.
• Apply structured problem-solving methods to determine causes and support risk-based decisions.
• Coordinate with owners, SMEs, and cross-functional users to obtain evidence and complete actions.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.
• Ensure investigation records are accurate, timely, and well-supported.
• Track milestones and maintain visibility of open actions for timely closure.
• Enter and maintain quality records in the eQMS; ETQ experience preferred.
• Support quality metrics, audits, and inspections; identify opportunities to improve processes.

Skills

Communication skills

CAPA/NC knowledge

Investigation management

Root cause analysis

Documentation

Cross-functional coordination

Prioritization

eQMS experience

Office software

Tools

ETQ eQMS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Microsoft Teams

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.