Quality Engineer, CAPA & NC Leader (Onsite)

Intuitive Surgical; East Point (GA); On-site; USD 125,000 - 183,000; Full time

Job summary

Intuitive Surgical in the United States is seeking a Quality Engineer to help ensure quality systems, products, and manufacturing processes comply with ISO 13485 and 21 CFR 820. You will lead NC/CAPA activities, perform data analysis, and drive timely corrective actions across cross‑functional teams.

You will mentor colleagues, support audits, and develop robust quality improvements that enhance patient safety and product reliability across the organization.

Qualifications

• Quality Engineer with 4+ years in regulated manufacturing (medical devices, pharma, etc.).
• Knowledge of 21 CFR820 and ISO 13485 required; exposure to CAPA/NC activities.
• Strong cross‑functional collaboration and data analysis skills.

Responsibilities

• Lead NC/CAPA projects and ensure timely, compliant records.
• Investigate issues, perform root-cause analysis, and escalate appropriately.
• Support audits and training, and mentor CAPA teams.

Skills

Quality Engineer

CAPA/NC processes

Regulated manufacturing

Root cause analysis

Data analysis

Cross-functional collaboration

Education

Engineering Bachelor's degree

Tools

Microsoft Excel

Job description

Intuitive Surgical in the United States is seeking a Quality Engineer to help ensure quality systems, products, and manufacturing processes comply with ISO 13485 and 21 CFR 820. You will lead NC/CAPA activities, perform data analysis, and drive timely corrective actions across cross‑functional teams.

You will mentor colleagues, support audits, and develop robust quality improvements that enhance patient safety and product reliability across the organization.