We are seeking an experienced Lead Auditor to conduct external supplier audits for medical device components, products, and services. This role is critical in ensuring that our supply base maintains robust, compliant, and effective Quality Management Systems (QMS) aligned with ISO 13485, ISO 9001, and/or applicable regulatory requirements. The Lead Auditor will evaluate supplier processes, identify risks, drive corrective action, and support qualification and requalification activities essential to patient safety and regulatory compliance.
**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 Man...