Senior Quality Systems Engineer – CAPA & Compliance

Terumo Neuro; California (MO); On-site; USD 120,000 - 170,000; Full time

Job summary

Terumo Neuro is seeking a Sr. Engineer, Quality Systems to actively maintain and improve quality systems in support of global regulatory requirements.

The role analyzes metrics, updates procedures, and drives CAPA/QAR/audit-related activities with cross-functional partners to ensure on-time delivery of corrective actions. The ideal candidate has 3–5 years in medical device quality/compliance, hands-on CAPA leadership, and strong knowledge of FDA regulations, GMP, and GMP-based documentation

Qualifications

• Bachelor's Degree in a related field. 3–5 years of quality assurance/compliance experience in medical devices preferred.
• Experience with FDA regulations, GMP, and Good Documentation Practices.
• Proven root cause investigation techniques and CAPA management.
• Strong written and verbal communication, and cross-functional collaboration.
• Ability to manage multiple projects and maintain CAPA records and audit readiness.
• Experience supporting internal and external audits (FDA/notified bodies).
• Proficient with MS Word/Excel/PowerPoint/Visio.

Responsibilities

• Maintain and improve quality systems to ensure regulatory compliance.
• Lead CAPA investigations and drive on-time closure with cross-functional teams.
• Prepare data and host CAPA Review Board meetings, audits, and inspection support.
• Develop and analyze quality system metrics and trends for process improvement.
• Create and revise procedures to ensure compliance and continuous improvement.
• Cross-train as internal auditor to support internal audit processes.

Skills

CAPA

FDA Regulations

Good Documentation Practices

Root Cause Analysis

Quality Systems

Internal Audits

Quality Metrics

Regulatory Compliance

GMP

Cross-functional Collaboration

Microsoft Office

Education

Bachelor's Degree

Tools

MS Word

Excel

PowerPoint

Visio

Outlook

Job description

Terumo Neuro is seeking a Sr. Engineer, Quality Systems to actively maintain and improve quality systems in support of global regulatory requirements.

The role analyzes metrics, updates procedures, and drives CAPA/QAR/audit-related activities with cross-functional partners to ensure on-time delivery of corrective actions. The ideal candidate has 3–5 years in medical device quality/compliance, hands-on CAPA leadership, and strong knowledge of FDA regulations, GMP, and GMP-based documentation