Quality Systems Engineer

Acestack; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Acestack is seeking a Quality Systems Engineer to join our Irvine, CA team. This onsite, full-time role focuses on leading CAPA and Nonconformance investigations in a medical device environment, with emphasis on containment, data collection, root-cause analysis, and corrective actions.

The ideal candidate has hands-on experience with CAPA/NC processes, strong documentation, and the ability to coordinate with cross-functional teams to ensure investigation closure and regulatory readiness.

Qualifications

• Experience in medical device quality systems.
• CAPA/NC investigation experience.
• Strong documentation, recording, and traceability skills.
• Ability to lead investigations from initiation to closure with evidence-based conclusions.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures.
• Lead investigations from initiation through containment, data collection, root cause analysis, and corrective actions.
• Apply problem-solving methods to determine causes of quality issues and support risk-based decisions.
• Coordinate with owners, process owners, SMEs, and cross-functional users to obtain objective evidence.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.
• Maintain accurate quality records in the eQMS and support audits and inspections.

Skills

CAPA/NC processes

Quality investigations

Structured problem solving

Cross-functional coordination

Documentation & traceability

Tools

ETQ

MS Office

Job description

Role: Quality Systems Engineer

Location: Irvine, CA (Onsite)

Fulltime Permanent

Job Description

Must Have Technical/Functional 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.