Senior Quality Engineer - Endoluminal Systems

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 128,000 - 216,000; Full time

Job summary

Intuitive Surgical is seeking a Senior Quality Engineer 4 for Endoluminal Systems in Sunnyvale. The role leads end-to-end quality investigations, risk assessments, CAPA programs, and cross-functional quality initiatives across design, manufacturing and supplier operations.

Requires extensive QE/QA experience in regulated environments, strong data analytics, and ability to mentor junior staff while ensuring GMP, ISO and FDA compliance.

Qualifications

• Minimum 8 years in QE/QA with engineering degree or equivalent.
• 2+ years in regulated industry in a relevant discipline.

Responsibilities

• Oversee end-to-end quality investigations across manufacturing, supplier, design, and customer complaints.
• Own CAPA and Process NCs; drive corrective actions.
• Lead risk assessments and process reviews; support audit preparations and responses.
• Analyze advanced quality data and KPI trends to inform decisions.
• Mentor junior engineers and technicians in quality practices.
• Ensure compliance with GMP, ISO, FDA and internal standards.
• Collaborate with cross-functional teams to meet quality requirements.

Skills

QE/QA experience

NPI transfer

Mechanical assembly

Inspection design

Quality principles

Data analysis

CAPA/NCs

Cross-functional leadership

Education

Bachelor's degree in engineering

Job description

Intuitive Surgical is seeking a Senior Quality Engineer 4 for Endoluminal Systems in Sunnyvale. The role leads end-to-end quality investigations, risk assessments, CAPA programs, and cross-functional quality initiatives across design, manufacturing and supplier operations.

Requires extensive QE/QA experience in regulated environments, strong data analytics, and ability to mentor junior staff while ensuring GMP, ISO and FDA compliance.