Accountabilities & Responsibilities
• Develop and maintain quality systems, processes, and procedures related to supplier quality management.
• Plan, schedule, and perform regular supplier audits to ensure compliance with company quality standards, regulatory requirements (e.g., ISO 13485, FDA), and contract specifications.
• Manage the supplier corrective action system by reviewing and prioritizing SCAR requests for completeness, coordinating SCAR tasks as appropriate, and compiling SCAR metrics for reporting.
• Track and analyze supplier performance using established metrics. Report on supplier performance to management, recommending corrective actions when necessary.
• Oversee and manage the ASL, ensuring that all suppliers are properly evaluated and qualified according to regulatory and company standards.
Review and approve new suppliers, re-qualify existing suppliers, and ensure the timely update of supplier records.
• Maintain accurate documentation related to supplier qualifications, audits, corrective actions, and performance metrics.
• Support the Supplier Management process in electronic Quality Management System by performing adminstrative tasks such as; coordinating supplier change evaluations, maintaining current supplier information, and recording results of metrics review.
• Ensure supplier evaluation and monitoring processes meet quality system requirements and company policies.
• Maintain and support administrative functions in quality management system software supplier modules as necessary.
• Other duties as assigned.