Quality Engineer II: Design Control & Process Excellence

Intuitive; Sunnyvale (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intuitive is seeking a Quality Engineer II to support product development and operations from concept to commercialization. You will contribute to design control, risk management, and process validation while ensuring compliance with GMP, ISO, and FDA requirements.

Responsibilities include cross-functional problem solving, audits support, and data-driven quality improvements across manufacturing and development teams. Strong root-cause analysis and statistical skills are essential.

Qualifications

• Experience with design control and risk management in medical devices.
• Familiarity with FDA guidance and ISO/ASTM standards related to quality.
• Ability to author clear technical documents and support audits.

Responsibilities

• Support manufacturing and work cross-functionally to resolve technical problems.
• Work closely with product development teams.
• Monitor priorities and track progress against schedules; communicate status to management.
• Provide support in the implementation and policing of GMP, ISO and FDA requirements.
• Experience and understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process Validation.
• Experience with product investigation, identifying root cause and implementing solutions.
• Familiarity with data analysis tools and statistical methods (ANOVA, DOE, etc.).
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root causes.
• Experience with SAP, TrackWise, Agile, etc.
• Experience in product design changes, manufacturing changes, supplier changes and associated requirements to execute changes.
• Support internal and external audits, including preparation and interaction with auditors.
• Support, designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Author technical documents with clarity and precision.
• Familiarity with FDA guidance documents and ISO/ASTM standards related to quality and medical devices is an asset.
• Other duties as assigned

Skills

Cross-functional teamwork

GMP/ISO/FDA knowledge

CAPA & NCM

Root cause analysis

Process validation

pFMEAs

Statistical methods (ANOVA/DOE)

Product investigation

Audits & regulatory readiness

Data analysis tooling

Tools

SAP

TrackWise

Agile

Job description

Intuitive is seeking a Quality Engineer II to support product development and operations from concept to commercialization. You will contribute to design control, risk management, and process validation while ensuring compliance with GMP, ISO, and FDA requirements.

Responsibilities include cross-functional problem solving, audits support, and data-driven quality improvements across manufacturing and development teams. Strong root-cause analysis and statistical skills are essential.