JOB DESCRIPTION

Job Title

Global Supplier Quality Lead Auditor

Job Description

Audit Planning & Preparation

Develop audit plans and agendas for external suppliers based on supplier classification, risk level, and regulatory requirements.

Review supplier performance data, previous audit results, and quality history to determine audit scope.

Ensure all required audit documentation is prepared prior to execution.

Execution of Supplier Audits

Lead remote and on‑site audits of suppliers’ Quality Management Systems to evaluate compliance with standards such as (but not limited to) ISO 13485 and ISO 9001.

Assess core supplier processes, including manufacturing controls, process validation, risk management, documentation practices, CAPA, and design transfer.

Apply risk‑based auditing principles and evaluate interdependencies across QMS processes.

Audit Reporting & Follow‑Up