Quality Systems Engineer - CAPA & Investigations (Medical Devices)

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

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