Senior SQE: ISO 13485 Lead Auditor (Remote)

Intuitive; Peachtree Corners (GA); À distance; USD 183 000 - 263 000; Plein temps

Avantages offerts par ce poste

Remote work

Résumé du poste

Intuitive Surgical is seeking a Staff Supplier Quality Engineer – ISO 13485 Lead Auditor, remote from the USA. This role leads global 3PL quality programs, audits, and regulatory compliance across the supply chain, reporting to the Director, Global Supply Chain Audits.

You will drive CAPAs, KPI tracking, and alignment with GDP, ISO 13485, and CFR Part 820 in a multinational environment. You’ll collaborate with operations, RAQA, and IT to improve QMS platforms (Trackwise, SAP, Agile) and ensure

Qualifications

• ISO 13485 Lead Auditor with multi-site audit experience.
• Expert knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, GDP requirements.
• Experience auditing global 3PLs, distribution networks, and service suppliers.
• Proficiency with Trackwise, SAP, and Agile for supplier file management and audit scheduling.
• Bachelor’s degree in Engineering or Life Sciences; typically 12+ years of related experience.

Responsabilités

• Lead global 3PL audits and supplier qualification.
• Develop and harmonize 3PL quality controls, KPIs, and supplier scorecards.
• Maintain QMS documentation, audit templates, and risk models.
• Support FDA inspections, Notified Body audits, and regulatory inspections.
• Mentor junior supplier quality engineers and drive CAPA effectiveness.

Connaissances

Lead auditor

3PL oversight

Regulatory compliance

Quality metrics

Formation

BS/BA in Engineering or Life Sciences

Outils

Trackwise

SAP

Agile

Description du poste

Intuitive Surgical is seeking a Staff Supplier Quality Engineer – ISO 13485 Lead Auditor, remote from the USA. This role leads global 3PL quality programs, audits, and regulatory compliance across the supply chain, reporting to the Director, Global Supply Chain Audits.

You will drive CAPAs, KPI tracking, and alignment with GDP, ISO 13485, and CFR Part 820 in a multinational environment. You’ll collaborate with operations, RAQA, and IT to improve QMS platforms (Trackwise, SAP, Agile) and ensure