Senior Quality Engineer, Medical Devices & CAPA Lead

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 127,000 - 128,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to independently own investigations across the Endoluminal product family and drive CAPA and continuous improvement. You will ensure compliance with GMP, ISO, and FDA standards while collaborating with cross-functional teams to reduce defects and improve product quality.

The role emphasizes data-driven decision making, effective communication, and mentorship within a team dedicated to safer, smarter

Qualifications

• Minimum 5 years of QE/QA experience and a bachelor’s degree.
• Solid data analysis and interpretation skills.
• Strong communication and teamwork abilities.

Responsibilities

• Own product, process and complaint investigations within the Endoluminal product family.
• Serve as escalation owner for low to medium impact product quality risks.
• Review and maintain test records and reports for completeness and accuracy.
• Lead CAPA and systemic process non-conformances.
• Assist in updating and revising QMS documentation.
• Lead risk assessment activities and process reviews.
• Analyze data for trends in defects and report to peers.
• Ensure compliance with GMP, ISO, FDA and internal standards.
• Contribute to project Core Team and stakeholder communications.
• Own continuous improvement projects across business units.

Skills

Quality principles

Data analysis

Communication

Team collaboration

Education

Bachelor's degree in engineering or related field

Tools

CAPA software

QMS software

Job description

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer to independently own investigations across the Endoluminal product family and drive CAPA and continuous improvement. You will ensure compliance with GMP, ISO, and FDA standards while collaborating with cross-functional teams to reduce defects and improve product quality.

The role emphasizes data-driven decision making, effective communication, and mentorship within a team dedicated to safer, smarter