Ingeniero de sistemas de calidad NC EMI

Role Overview

We are seeking a Quality Systems Engineer to join our team in Tijuana, Mexico. The successful candidate will be responsible for creating procedures and forms to support the Quality Management system, participating in quality audits, and maintaining data integrity. The role will also involve coordinating with various teams to ensure effective investigation and disposition of Non-Conforming product/material.

What You Will Do

The Quality Systems Engineer will create necessary procedures and forms, participate in internal and external quality audits, maintain data integrity, and coordinate with various teams to ensure effective investigation and disposition of Non-Conforming product/material. The role will also involve generating and maintaining metrics, identifying patterns or systemic issues, and recommending improvements.

Why It Might Be a Fit

We are looking for a candidate with a strong understanding of FDA, ISO, and ANSI regulations and standards. The successful candidate will be able to work independently, handle routine tasks with attention to detail, and ensure data accuracy and consistency across systems and reports.

Requirements

• Familiarity with FDA, ISO, and ANSI regulations and standards
• Ability to create procedures and forms to support the Quality Management system
• Participation in internal, external, and 3rd party quality audits
• Maintenance of data integrity and audit readiness of all NC records
• Coordination with Quality Engineering, Manufacturing, Supply Chain, and Supplier Quality

Benefits

• Equal Opportunity Employer
• Face-to-face collaboration supports learning, progress, and success