Ingeniero de Calidad de Inspección de entrada

The Incoming / Supplier Quality Engineer is responsible for ensuring consistent quality of materials, components, and purchased products through the establishment and enforcement of quality standards. This includes inspecting and releasing incoming materials, monitoring suppliers’ daily quality performance, preparing quality reports, and implementing corrective action programs.

This role is essential to ensure that the processes defined for product manufacturing incorporate all required quality standards from the receiving stage. The position works closely with the Purchasing, Engineering, and Production departments, providing technical support and assisting in supplier selection and evaluation from a quality perspective when required.

The position ensures compliance with applicable requirements of the Quality and Environmental Management System, including ISO 9001, ISO 13485, FDA QMSR (21 CFR 820), and ISO 14001.

1. Material Inspection and Release

• Verify raw materials, components, and purchased products against engineering drawings, specifications, and applicable standards.
• Perform visual, dimensional, and functional inspections.
• Authorize the release or rejection of received materials.
• Identify, segregate, and control nonconforming material.

2. Safety and Certification Compliance

• Coordinate compliance with safety requirements during incoming material inspections.
• Review and verify requirements from certification bodies such as UL, TÜV, CQC, and others as applicable.

3. Nonconformance and CAPA Management 

• Document material rejections and Nonconformance Reports (NCRs).
• Perform root cause analysis of recurring defects using tools such as 5 Whys, Ishikawa (Fishbone), Pareto, etc.
• Follow up on corrective and preventive actions (CAPA).
• Coordinate rework, returns, or use-as-is concessions with cross-functional teams.

4. Documentation and Regulatory Control

• Ensure compliance with applicable quality and regulatory standards (ISO 9001, ISO 13485, 21 CFR 820, ISO 14001).