Quality Engineer - Endoluminal Medical Devices

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 108,000 - 183,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale seeks a Quality Engineer (Finance) to independently own quality projects, investigations, and CAPA across the Endoluminal product platform, covering design, manufacturing and service.

The role emphasizes data-driven decision making, risk assessment, and cross-functional collaboration. You will review test records, drive continuous improvement, and ensure adherence to GMP, ISO, and FDA standards while mentoring junior QEs and communicating findings to

Qualifications

• Minimum 5 years of experience in QE/QA with a Bachelor's degree in engineering or equivalent.
• Solid understanding of quality principles and methodologies.
• Experience with data analysis and root-cause investigations.
• Ability to identify and resolve quality issues independently.
• Strong communication and teamwork across functions.
• Keeping up-to-date with GMP, ISO, and FDA requirements.

Responsibilities

• Own quality projects, investigations, inspections, and CAPA within the Endoluminal product platform.
• Serve as escalation owner for low to medium impact quality risks.
• Review and maintain test records and reports for completeness and accuracy.
• Lead continuous improvement initiatives and update QA documentation.
• Perform risk assessments and participate in process reviews.
• Analyze defect trends and report findings to stakeholders regularly.
• Ensure compliance with GMP, ISO, and FDA standards.

Skills

Quality principles

Data analysis

Issue resolution

Communication

Team collaboration

Regulatory awareness

Education

Bachelor's degree in engineering or relevant discipline

Job description

Intuitive Surgical, Inc. in Sunnyvale seeks a Quality Engineer (Finance) to independently own quality projects, investigations, and CAPA across the Endoluminal product platform, covering design, manufacturing and service.

The role emphasizes data-driven decision making, risk assessment, and cross-functional collaboration. You will review test records, drive continuous improvement, and ensure adherence to GMP, ISO, and FDA standards while mentoring junior QEs and communicating findings to