CAPA/NCR Quality Engineer – Root Cause & Compliance

Terumo Aortic; Renfrew; On-site; GBP 42,000 - 65,000; Full time

Job summary

Terumo Aortic is seeking a Quality Engineer focused on NCR/CAPA to support investigation plans, containment actions and effectiveness tracking. You will drive CAPA/NCR investigations, lead cross-functional teams and collaborate with Risk, QA and regulatory functions to ensure timely closure and robust documentation.

The role emphasizes data-driven analysis, use of Lean principles, and ongoing improvement of QMS processes within a global medical device environment.

Qualifications

• Relevant science/engineering degree required.
• Six Sigma Green Belt desirable; knowledge of CAPA, NCR, RCA and Trending.

Responsibilities

• Maintain CAPA/NCR processes and dashboards.
• Lead CAPA/NCR teams through initiation, investigation, action plan and effectiveness steps.
• Support NCR processes, risk assessments and containment actions.
• Provide data trending and status updates to QA leadership and boards.

Skills

Six Sigma Green Belt

CAPA/NCR knowledge

Root Cause Analysis

Statistical analysis

Cross-functional collaboration

Problem-solving

Quality management systems

Education

Science/Engineering degree

Tools

Minitab

Job description

Terumo Aortic is seeking a Quality Engineer focused on NCR/CAPA to support investigation plans, containment actions and effectiveness tracking. You will drive CAPA/NCR investigations, lead cross-functional teams and collaborate with Risk, QA and regulatory functions to ensure timely closure and robust documentation.

The role emphasizes data-driven analysis, use of Lean principles, and ongoing improvement of QMS processes within a global medical device environment.