Senior Quality Engineer – Endoluminal Systems Leader

Socket.dev; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a senior QE/QA professional to oversee end-to-end quality investigations across manufacturing, supplier, and design activities. You will own CAPA, risk assessments, and regulatory readiness, mentoring junior engineers and guiding cross‑functional teams to ensure GMP/ISO compliance.

The role requires an engineering degree and 8+ years in QE/QA in regulated environments, with strong data analysis and cross-team collaboration

Qualifications

• 8+ years in QE/QA with a bachelor’s in engineering or equivalent.
• At least 2 years in a regulated industry (e.g., FDA, GMP).

Responsibilities

• Lead critical product/process investigations with cross-site impact.
• Drive CAPA and process NCs; own risk assessments and process reviews.
• Prepare for/regulatory and customer audits; respond to inquiries.
• Mentor junior QEs; influence stakeholders across departments.

Skills

Quality investigations

CAPA

Data analysis

Regulatory coordination

Cross-functional leadership

QA documentation

Mentoring

Education

Bachelor's degree in engineering or relevant discipline

Tools

QA tools

Job description

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a senior QE/QA professional to oversee end-to-end quality investigations across manufacturing, supplier, and design activities. You will own CAPA, risk assessments, and regulatory readiness, mentoring junior engineers and guiding cross‑functional teams to ensure GMP/ISO compliance.

The role requires an engineering degree and 8+ years in QE/QA in regulated environments, with strong data analysis and cross-team collaboration