**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**
+ Prepare clear and comprehensive audit reports outlining findings, evidence, and recommendations.
+ Communicate audit outcomes to suppliers and i...