Quality Engineer II: Design, Risk & Compliance

Intuitive; California (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Intuitive is seeking a Quality Engineer II to join our team in supporting product development and operations from concept through commercialization. You will ensure quality processes align with GMP, ISO, and FDA requirements while collaborating with cross-functional teams on design control, risk management, and process validation.

You will investigate root causes, apply CAPAs, and provide statistical support using methods like ANOVA and DOE to drive continuous improvement in manufacturing and

Qualifications

• Experience with GMP, ISO and FDA requirements.
• Strong root cause analysis and CAPA experience.
• Knowledge of pFMEAs and process validation.
• Familiarity with SAP, Trackwise, and Agile systems.

Responsibilities

• Support manufacturing and work cross-functionally to resolve technical problems
• Work closely with product development teams.
• Monitor priorities and tracks progress against schedules; and communicates status to management.
• Provide support in the implementation and policing of GMP, ISO and FDA requirements.
• Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process Validation
• Experience with product investigation, Identifying root cause and implementing appropriate solutions
• Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
• Experience with computerized systems, such as SAP, Trackwise, Agile, etc.
• Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes.
• Support internal and external audits, including preparation and direct interaction with auditors.
• Support, designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.

Skills

Root cause analysis

CAPA

Process validation

Statistical methods (ANOVA, DOE)

Tools

SAP

Trackwise

Agile

Job description

Intuitive is seeking a Quality Engineer II to join our team in supporting product development and operations from concept through commercialization. You will ensure quality processes align with GMP, ISO, and FDA requirements while collaborating with cross-functional teams on design control, risk management, and process validation.

You will investigate root causes, apply CAPAs, and provide statistical support using methods like ANOVA and DOE to drive continuous improvement in manufacturing and