Quality Engineer II: MedTech Impact & Process Excellence

8286-Cordis De Mexico Legal Entity; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Juarez, Mexico is seeking a Quality Engineer II to join its MedTech quality team. Under general supervision, you will support design verification tests, process validations, and QA activities to ensure compliance with FDA, ISO 13485, and MDR requirements.

The role emphasizes problem solving, data analysis, and collaboration with suppliers and manufacturing teams to deliver safe, effective medical devices throughout product lifecycle.

Formación

• Bachelor’s degree in a related field with 2–4 years of quality, manufacturing, or R&D in medical devices.
• ASQ certification, Six Sigma experience, and GD&T knowledge desirable.
• Experience applying quality systems in regulated environments (FDA, ISO 13485, QSR).

Responsabilidades

• Support new product development, sustaining, and supply chain quality projects.
• Write validation protocols and reports; perform equipment qualifications.
• Use statistics to analyze data, make acceptance decisions, and improve process capability.
• Ensure compliance with design control, MDR, and regulatory requirements; assist in CAPA activities.
• Coordinate with Regulatory Affairs on submissions for process changes and new devices.

Conocimientos

Problem solving

Verbal communication

Written communication

Educación

Bachelor's degree in related field

Master's degree preferred

Descripción del empleo

Johnson & Johnson in Juarez, Mexico is seeking a Quality Engineer II to join its MedTech quality team. Under general supervision, you will support design verification tests, process validations, and QA activities to ensure compliance with FDA, ISO 13485, and MDR requirements.

The role emphasizes problem solving, data analysis, and collaboration with suppliers and manufacturing teams to deliver safe, effective medical devices throughout product lifecycle.