Supplier Quality Engineer

Position Overview :

We are seeking an experienced and driven Supplier Quality Engineer (SQE ) to lead supplier quality initiatives, manage supplier performance, and ensure compliance with internal and external quality standards. This role is critical in building a robust supply base that supports product excellence and regulatory compliance.

Responsibilities :

• Evaluate and qualify new suppliers through audits, assessments, and technical reviews.
• Monitor supplier performance using KPIs such as PPM, on-time delivery, and quality metrics.
• Lead supplier-related investigations for nonconforming materials and components, including root cause analysis and corrective actions.
• Conduct supplier audits (remote and on-site) and support supplier development programs.
• Manage Supplier Corrective Action Requests (SCARs) and ensure timely and effective resolution.
• Collaborate with Procurement, Engineering, and Manufacturing to address supplier issues and improve quality outcomes.
• Develop and maintain supplier quality agreements and ensure compliance with applicable standards (e.g., ISO 13485, FDA QSR, EU MDR, and risk management per ISO 14971).
• Support incoming inspection processes and define acceptance criteria for critical components.
• Conduct periodic supplier audits and participate in supplier development initiatives.
• Maintain documentation and records in accordance with regulatory and internal requirements.
• Other duties as assigned.

Qualification :