Quality Engineer (Tijuana)

Responsabilidades

• Provide Quality review for product design changes.
• Review Design History Files (DHF) for accuracy and compliance to internal and regulatory (FDA) requirements.
• Evaluate and investigate customer complaints: Includes failure analysis and resolution through an electronic system.
• Generate statistical reports on quality performance in the process and in the product: Review quality data trending to determine if action(s) need to take place.
• Execute CAPA (Corrective and Preventive Action) tools as required, both internally and externally, to bring about the desired changes and continuous improvement.
• Represent Quality on various teams, including ISO and/or FDA Audits, providing data information as needed, including internal audits.

Requisitos

• Engineer's degree (Industrial, Mechanical) minimum of five years of quality or related discipline and/or equivalent combination of education an...