Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer is responsible for managing and ensuring the quality and compliance of suppliers. The Senior Supplier Quality Engineer will conduct supplier audits, maintain the Approved Supplier List (ASL), monitor supplier performance through metrics, and oversee supplier-related quality activities to ensure that all products and materials meet regulatory requirements and internal quality standards. Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.).

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