Quality Engineer II - Medical Devices & Compliance

Biopharma Careers; Ciudad Juárez; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking a Quality Assurance professional to participate in new product development, sustaining activities, and supplier quality initiatives. You will develop quality control plans, verify designs, and ensure compliance with FDA, ISO 13485, and MDR requirements throughout product lifecycles.

The role emphasizes defect analysis, CAPA, and continuous improvement, with opportunities to collaborate across regulatory affairs and manufacturing to maintain product quality and safety.

Formación

• Bachelor’s degree in a related field with 2–4 years in quality, manufacturing, or R&D for medical devices.
• Master’s degree is preferred.
• ASQ certification, Six Sigma, or Process Excellence tools desirable.
• Familiarity with GD&T concepts desirable.

Responsabilidades

• Assist in developing quality-engineered systems and processes.
• Lead design verification tests and process validations.
• Write validation protocols and reports, equipment qualifications, and change orders.
• Use statistical tools to analyze data and improve process capability.
• Support supplier quality and quality-related audits as needed.

Educación

Bachelor’s degree in a related field

Master’s degree

Herramientas

ASQ certification

Six Sigma

GD&T concepts

Descripción del empleo

Johnson & Johnson is seeking a Quality Assurance professional to participate in new product development, sustaining activities, and supplier quality initiatives. You will develop quality control plans, verify designs, and ensure compliance with FDA, ISO 13485, and MDR requirements throughout product lifecycles.

The role emphasizes defect analysis, CAPA, and continuous improvement, with opportunities to collaborate across regulatory affairs and manufacturing to maintain product quality and safety.