Quality & CAPA Engineer — Medical Devices (Onsite)

Intuitive; Peachtree Corners (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Quality Engineer focused on NC/CAPA, ISO 13485, and 21 CFR 820 compliance. You will partner with cross-functional teams to drive improvements and ensure timely escalation of quality issues in a fast-paced medical-device environment.

You will lead NC/CAPA projects, support audits, and mentor others while applying Six Sigma tools and robust data analysis to elevate product quality and regulatory compliance across sites.

Qualifications

• Experience as a Quality Engineer in a regulated manufacturing environment (medical devices) preferred.
• Strong knowledge of 21 CFR 820 and ISO 13485.
• Experience with NC/CAPA processes and quality tools.
• Proficient data analysis, root cause analysis, and reporting.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead NC/CAPA projects and ensure timely closure.
• Investigate quality issues and drive robust CAPA actions.
• Support audits and inspections with SME input.
• Collaborate with cross-functional teams using Six Sigma methodologies.
• Mentor others in NC/CAPA processes.

Skills

Quality Engineer experience

Regulated manufacturing

CAPA/NC experience

cGMP knowledge

Data analysis

Root cause analysis

Project management

Communication skills

Education

Engineering Bachelor's degree

Tools

Microsoft Office

Quality tools (Lean, Six Sigma)

ISO 13485

Job description

Intuitive Surgical is seeking a Quality Engineer focused on NC/CAPA, ISO 13485, and 21 CFR 820 compliance. You will partner with cross-functional teams to drive improvements and ensure timely escalation of quality issues in a fast-paced medical-device environment.

You will lead NC/CAPA projects, support audits, and mentor others while applying Six Sigma tools and robust data analysis to elevate product quality and regulatory compliance across sites.