Med Devices CI Quality Engineer: CAPA & Six Sigma

Intuitive; Georgia; On-site; USD 85,000 - 125,000; Full time

Job summary

Intuitive in the United States is seeking a Quality Engineer to ensure quality systems, products, and manufacturing processes meet ISO 13485 and 21 CFR 820 standards while driving NC/CAPA improvements. You will partner with cross-functional teams, lead CAPA projects, and mentor colleagues on NC/CAPA processes, applying Six Sigma tools and data analysis to prevent quality issues.

This role requires a bachelor’s degree and at least four years in a regulated manufacturing environment, with strong

Qualifications

• Engineering Bachelor’s degree; preferably in science or healthcare fields.

Responsibilities

• Support and comply with Health, Safety, and Environmental programs, including use of PPE.
• Report unsafe acts/conditions to superiors and participate in training.
• Maintain 5S workspace and ensure equipment is in good condition.
• Comply with ISO13485 and 21 CFR820 requirements and site policies.
• Participate in or lead NC & CAPA projects with timely documentation.
• Lead meetings for NC/CAPA updates and communicate with stakeholders.

Skills

Quality Engineering

CAPA

NC/CAPA

21 CFR 820

ISO 13485

Six Sigma

Root cause analysis

Data analysis

Documentation

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Intuitive in the United States is seeking a Quality Engineer to ensure quality systems, products, and manufacturing processes meet ISO 13485 and 21 CFR 820 standards while driving NC/CAPA improvements. You will partner with cross-functional teams, lead CAPA projects, and mentor colleagues on NC/CAPA processes, applying Six Sigma tools and data analysis to prevent quality issues.

This role requires a bachelor’s degree and at least four years in a regulated manufacturing environment, with strong