Quality Engineer II - MedTech Quality & Compliance

Johnson & Johnson MedTech

Ciudad Juárez

Presencial

MXN 420.000 - 540.000

Jornada completa

Hace 2 días
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Descripción de la vacante

Johnson & Johnson MedTech in Horizontes Plant, Juarez, Chihuahua, is seeking a Quality Engineer II to join the quality organization. You will participate in new and sustaining product teams, lead verification tests, and ensure compliance with FDA, ISO 13485, CMDCAS, PMDA and other global standards.

Responsibilities include developing quality control plans, performing process validations, CAPA handling, and supporting supplier quality.

Formación

  • Bachelor's degree in a related field (required).
  • 2-4 years quality, manufacturing, or R&D in medical devices in regulated environment.
  • Master's degree preferred.
  • ASQ certification and Six Sigma knowledge desirable.
  • GD&T familiarity desirable.
  • GMP/QSR knowledge for medical devices desirable.
  • Strong problem solving and communication skills.

Responsabilidades

  • Assist in new product development, sustaining, and supply chain quality projects.
  • Write validation protocols, qualification reports, and CAPA as needed.
  • Support design transfer and validation testing per standards (FDA/ISO).
  • Analyze data with statistical tools to improve process capability.
  • Ensure compliance with Quality System policies and regulatory requirements.

Conocimientos

Problem solving
Verbal and written communication
Project management
Quality engineering

Educación

Bachelor's degree in related field
Master's degree preferred

Herramientas

GD&T familiarity
Six Sigma
SPC & DOE

Descripción del empleo

Johnson & Johnson MedTech in Horizontes Plant, Juarez, Chihuahua, is seeking a Quality Engineer II to join the quality organization. You will participate in new and sustaining product teams, lead verification tests, and ensure compliance with FDA, ISO 13485, CMDCAS, PMDA and other global standards.

Responsibilities include developing quality control plans, performing process validations, CAPA handling, and supporting supplier quality.

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