Quality Systems Engineer

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

Job summary

Creative Solutions Services, LLC in Irvine, CA is seeking a highly organized Quality Systems Engineer to support CAPA, NC investigations, and quality-system documentation in a regulated medical-device environment. You will apply structured problem-solving and risk-based assessments to ensure compliant, evidence-based closures.

Collaborating with Quality, Manufacturing, Engineering, Regulatory, and other teams, you will maintain eQMS records, track milestones, and drive process improvements while

Qualifications

• 3+ years in Quality Engineering or related role in the medical-device industry.
• Hands-on CAPA and NC investigations experience.
• Experience leading investigations through lifecycle from containment to closure.

Responsibilities

• Manage and execute CAPA and Nonconformance investigations.
• Apply root-cause analysis to identify underlying issues.
• Conduct risk-based assessments with objective evidence.
• Collaborate with cross-functional teams to resolve issues.
• Maintain quality records in the eQMS and ensure inspection-readiness.
• Monitor milestones, actions, and escalations for timely closure.
• Ensure compliance with procedures and regulatory requirements.
• Identify recurring quality issues and drive improvements.

Skills

CAPA investigations

Nonconformance investigations

Root-cause analysis

Quality system knowledge

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline

Preferred: Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering, or related field

Tools

eQMS

Job description

Job Summary

We are seeking a highly organized and detail-oriented Quality Systems Engineer to support quality system activities within a regulated medical-device environment. Theideal candidate will have hands-on experience with CAPA, Nonconformance (NC) investigations, root-cause analysis,corrective actions, and quality-system documentation.

Roles & Responsibilities

• Manage and execute CAPA and Nonconformance (NC) investigation s in accordance with established procedures, quality-system requirements, and applicable medical-device regulations.
• Apply structured problem-solving and root-cause analysis methodologies to identify and address the underlying causes of quality issues.
• Conduct risk-based assessments and ensure investigation conclusions are supported by objective evidence, sound rationale, and appropriate documentation.
• Partner with investigation owners, process owners, subject-matter experts, and cross-functional stakeholders to collect evidence, resolve issues, and complete assigned actions.
• Facilitate investigation follow-up meetings and document decisions, action items, risks, dependencies, and escalations.
• Monitor and communicate investigation status, milestones, overdue actions, risks, and potential escalation requirements.
• Ensure CAPA, NC, and investigation records are accurate, complete, clear, timely, traceable, and inspection-ready.
• Track investigation milestones, action items, commitments, and due dates to support timely closure.
• Enter, update, review, route, and maintain quality records within the applicable electronic Quality Management System (eQMS).
• Support quality-system activities, documentation reviews, audits, and inspection-readiness initiatives.
• Maintain effective follow-up and coordination across multiple investigations and quality-system deliverables.
• Ensure activities are performed in compliance with company procedures, quality policies, and applicable regulatory requirements.
• Identify recurring quality issues, trends, and opportunities for process improvement and communicate findings to relevant stakeholders.
• Collaborate effectively with Quality, Manufacturing, Engineering, Operations, Regulatory, and other cross-functional teams.

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• Preferred: Degree in Biomedical, Mechanical, Electrical, Chemical, Industrial Engineering, or a related field.
• 3+ years of experience in Quality Engineering, Quality Systems, Quality Assurance, or a related role within the medical-device industry.
• Hands-on experience managing CAPA and Nonconformance (NC) investigations in a regulated environment.
• Demonstrated experience leading investigations through the complete lifecycle, including containment, issue definition/bounding, data collection, root-cause analysis, corrections, corrective actions, and closure.