Remote: Senior SQE | ISO 13485 Lead Auditor

Intuitive; Oregon; Hybrid; USD 156,000 - 263,000; Full time

Job summary

Intuitive is seeking a Staff Supplier Quality Engineer to independently define methodologies and audit frameworks for the global supply chain, focusing on 3PL quality management and supplier qualification. You will lead risk-based audits, ensure GDP and ISO/GxP compliance, and drive CAPA effectiveness across international sites.

Reporting to the Director, Global Supply Chain Audits, you will partner with cross-functional teams to improve 3PL performance, qualification processes, and QMS software

Qualifications

• BS/BA in Engineering, Life Sciences, or related field.
• Minimum 12 years related experience with a Bachelor's; 8 years with a Master's; 5 years with a PhD or equivalent.
• Significant experience in high-volume, globally distributed medical devices or GxP environments.
• Lead Auditor experience with ISO 13485, GDP, and 21 CFR Part 820 is preferred.

Responsibilities

• Lead and execute risk-based audits for global 3PL providers, distribution hubs and service suppliers.
• Design and update audit master schedules, risk models, and reporting templates.
• Conduct audits to GDP, ISO 13485, ISO 17025, and other regulatory standards.
• Drive root-cause analysis and manage CAPA with 3PL leadership.

Skills

Lead Auditor

3PL Audits

Regulatory Knowledge

Risk Management

Cross-functional Collaboration

Education

BS/BA in Engineering or Life Sciences

Tools

Trackwise

SAP

Agile

Job description

Intuitive is seeking a Staff Supplier Quality Engineer to independently define methodologies and audit frameworks for the global supply chain, focusing on 3PL quality management and supplier qualification. You will lead risk-based audits, ensure GDP and ISO/GxP compliance, and drive CAPA effectiveness across international sites.

Reporting to the Director, Global Supply Chain Audits, you will partner with cross-functional teams to improve 3PL performance, qualification processes, and QMS software