Senior Quality Engineer — Healthcare, CAPA & Data

Regulatory Jobs; Sunnyvale (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Intuitive Surgical is seeking a Quality Engineer/QA professional to own product, process and complaint investigations within the Endoluminal family. You will serve as escalation owner for quality risks and ensure records meet GMP, ISO and FDA standards.

The role requires at least 5 years of QE/QA experience and a bachelor’s degree in engineering or a related field. You will lead CAPA activities, support QMS updates and collaborate with cross-functional teams to deliver safe, high-quality medical

Qualifications

• Minimum 5 years of QE/QA experience with a bachelor’s degree in engineering.
• Bachelor’s degree in engineering or relevant discipline required.
• Equivalent education/experience acceptable.

Responsibilities

• Own product, process and complaint investigations within the Endoluminal product family.
• Serve as escalation owner for low to medium impact quality risks.
• Review and maintain test records and reports for accuracy.
• Lead CAPA and systemic process non-conformances.
• Assist in updating QMS documentation.
• Leads risk assessment activities and process reviews.
• Analyze data for trends in defects and report out to peers.
• Ensure compliance with GMP, ISO, FDA standards.
• Be an integral member of a project Core Team and contribute to success.
• Communicate findings and recommendations to stakeholders.
• Ownership of continuous improvement projects with various levels of scope.

Skills

Quality principles

Data analysis

Issue resolution

Communication

Learning & updating

Education

Bachelor's degree in engineering or related discipline

Job description

Intuitive Surgical is seeking a Quality Engineer/QA professional to own product, process and complaint investigations within the Endoluminal family. You will serve as escalation owner for quality risks and ensure records meet GMP, ISO and FDA standards.

The role requires at least 5 years of QE/QA experience and a bachelor’s degree in engineering or a related field. You will lead CAPA activities, support QMS updates and collaborate with cross-functional teams to deliver safe, high-quality medical