Supplier Quality Engineer - SQE

The Supplier Quality Engineer (SQE) is responsible for ensuring that suppliers consistently meet quality, regulatory, and business requirements for materials, components, and services used in the manufacturing of medical devices. This position works closely with suppliers, Purchasing, Manufacturing, Engineering, and Quality teams to drive supplier performance, resolve quality issues, and support continuous improvement initiatives.

• Evaluate, qualify, and monitor suppliers to ensure compliance with quality and regulatory requirements.
• Conduct supplier audits in accordance with ISO 13485, FDA regulations, and internal quality standards.
• Manage supplier performance through quality metrics, scorecards, and continuous improvement programs.
• Lead Supplier Corrective Action Requests (SCARs) and verify the effectiveness of corrective actions.
• Investigate supplier-related nonconformances and coordinate root cause analysis activities.
• Collaborate with cross-functional teams to address supplier quality issues and implement corrective and preventive actions.
• Review and approve supplier documentation, including Certificates of Compliance, First Article Inspection Reports, validation documentation, and quality agreements.
• Support New Product Introductions (NPI), product transfers, and supplier change management activities.
• Participate in risk assessments related to suppliers, materials, and manufacturing processes.
• Support incoming inspection and supplier-related quality improvement projects.
• Ensure compliance with applicable regulatory requirements, including FDA, ISO 13485, and customer-specific requirements.
• Maintain supplier quality records and documentation required for internal, customer, and regulatory audits.