Quality Engineer — Injection Molding & ISO 13485

INNOVA THERMOFAB MEXICALI

• Establish and maintain detailed quality documentation, including control plans, process flow diagrams, PFMEA, and inspection plans. ISO Lead Auditor Certification.
• Ability to support inspection of first articles, in-process parts, and products prior to shipment using gauges, coordinate measuring machines, optical comparators, and vision.
• Ability to perform measurements and data collection in support of SPC activities and product validations.

• 3+ years of experience as a Quality Engineer in an injection molding or similar manufacturing environment.
• Experience in molding process, mold validation, and direct participation in molded part transfer projects.
• Support the implementation, maintenance, and continuous improvement of the ISO 13485 Quality Management System.
• Develop, document, and revise quality procedures, create work instructions, and policies to align with ISO standard...