Quality Engineer: Medical Device, Data-Driven CAPA Leader

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted care, seeks a Quality Engineer to own quality projects within the Endoluminal product platform. You will manage investigations, CAPA, data analysis, and cross-functional collaboration to drive improvements and compliance with GMP, ISO, and FDA standards.

The role emphasizes risk assessment, QMS updates, and communication with stakeholders. Travel is minimal, and a strong emphasis on quality culture and continuous improvement pervades the

Qualifications

• QE/QA experience required or equivalent
• Strong data interpretation and decision-making skills
• Excellent collaboration and stakeholder communication

Responsibilities

• Own product, process and complaint investigations within the Endoluminal product family
• Serve as escalation owner for quality risks
• Review and maintain test records and reports for accuracy
• Lead CAPA and non-conformances across processes
• Update and revise QMS documentation
• Lead risk assessment activities and process reviews
• Analyze data for trends in defects and report findings
• Ensure compliance with GMP, ISO, FDA standards
• Communicate findings to stakeholders
• Drive continuous improvement initiatives

Skills

Quality principles

Data analysis

Issue resolution

Communication & collaboration

Standards & tools awareness

Education

Bachelor's degree in engineering or related field

Job description

Intuitive Surgical, a global leader in robotic-assisted care, seeks a Quality Engineer to own quality projects within the Endoluminal product platform. You will manage investigations, CAPA, data analysis, and cross-functional collaboration to drive improvements and compliance with GMP, ISO, and FDA standards.

The role emphasizes risk assessment, QMS updates, and communication with stakeholders. Travel is minimal, and a strong emphasis on quality culture and continuous improvement pervades the