Senior Quality Engineer - Medical Device Impact

Socket.dev; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive Surgical is seeking a Quality Engineer to independently own quality projects across Endoluminal product platforms. You will drive investigations, CAPA activities, and improvement initiatives while ensuring GMP/ISO/FDA compliance within design, manufacturing and service contexts.

Ideal candidates have 5+ years in QE/QA with a bachelor’s degree in engineering, strong data analysis skills, and excellent communication to collaborate with cross-functional teams that include developers,

Qualifications

• Solid understanding of quality principles and methodologies.
• Strong data analysis and data interpretation skills.
• Identify and resolve quality issues independently.
• Strong communication, presentation and team collaboration.
• Staying updated with evolving standards, tools and technologies.

Responsibilities

• Independently owns quality projects, investigations and CAPA activities.
• Serves as escalation owner for product quality risks.
• Review and maintain test records and reports for accuracy.
• Lead risk assessments and process reviews.
• Communicate findings and recommendations to stakeholders.
• Own continuous improvement initiatives across scope levels.

Skills

Quality principles

Data analysis

Independent issue resolution

Communication & collaboration

Regulatory awareness

Education

Bachelor's degree in engineering

Job description

Intuitive Surgical is seeking a Quality Engineer to independently own quality projects across Endoluminal product platforms. You will drive investigations, CAPA activities, and improvement initiatives while ensuring GMP/ISO/FDA compliance within design, manufacturing and service contexts.

Ideal candidates have 5+ years in QE/QA with a bachelor’s degree in engineering, strong data analysis skills, and excellent communication to collaborate with cross-functional teams that include developers,