Global Supplier Quality Lead Auditor

Job description

Job Title Global Supplier Quality Lead Auditor Job Description: Global Supplier Quality Lead Auditor The Global Supplier Quality Lead Auditor will 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. Your role: - Develop tailored audit plans and agendas for external suppliers by considering their classification, risk level, and regulatory requirements, ensuring all documentation is prepared in advance. - Lead remote and on-site audits of suppliers' Quality Management Systems, evaluating compliance with ISO standards and assessing critical processes such as manufacturing controls, risk management, and CAPA. - Apply risk-based auditing principles to examine interdependencies across QMS processes and accurately determine audit scope using supplie...