Senior Quality Engineer, MedTech CAPA & Compliance Lead

Intuitive; Sunnyvale (CA); On-site; USD 150,000 - 216,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a senior QA/QA engineer to oversee end-to-end quality investigations across multiple operations and product families.

You will lead cross-functional teams, drive CAPA and risk assessment activities, and mentor junior engineers. The role requires robust experience in regulated environments (GMP/ISO/FDA) and hands-on quality analytics.

Qualifications

• Minimum 8 years of experience in QE/QA.
• At least 2 years in a regulated industry.
• Experience in supporting NPI from design to manufacturing transfer.

Responsibilities

• Lead critical product and process investigations with cross functional teams.
• Identify systemic quality issues and drive sustainable solutions.
• Own quality investigations for complaints and non-conformances.
• Drive CAPA and process NCs.
• Support regulatory and customer audit preparations.

Skills

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Data analysis

CAPA management

Education

Bachelor's degree in engineering or related field

Tools

QA documentation

NPI support

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a senior QA/QA engineer to oversee end-to-end quality investigations across multiple operations and product families.

You will lead cross-functional teams, drive CAPA and risk assessment activities, and mentor junior engineers. The role requires robust experience in regulated environments (GMP/ISO/FDA) and hands-on quality analytics.