Senior Quality Engineer – MedTech (18-Month Contract)

Antler; Ciudad Juárez; Presencial; MXN 480.000 - 800.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech in Ciudad Juárez seeks a Senior Quality Engineer (Fixed Term 18 months) to join the Quality Engineering team. You will lead quality activities across development, validation, and lifecycle processes, ensuring compliance with FDA, ISO 13485, and MDR standards.

You will collaborate with cross-functional groups to drive CAPA, supplier quality, and design control efforts while mentoring junior engineers and maintaining rigorous documentation.

Formación

• Bachelor’s degree in a related field with 4–6 years in quality/manufacturing/R&D in medical devices or regulated industries.
• ASQ certification and Six Sigma experience are desirable.
• GD&T knowledge is desirable; GMP and QSR knowledge required for medical devices.

Responsabilidades

• Lead quality engineering activities for new product development and transfers.
• Write, review and approve QA protocols, reports, and validation plans.
• Support CAPA, complaints analysis, and supplier quality activities.
• Perform risk management planning and maintain quality documentation across lifecycle.
• Participate in design reviews and pre-validation assessments to ensure regulatory compliance.

Conocimientos

Quality engineering

GMP knowledge

QSR knowledge

Six Sigma

Data analysis

Auditing

Educación

Bachelor’s degree in a related field

Master’s degree preferred

Descripción del empleo

Johnson & Johnson MedTech in Ciudad Juárez seeks a Senior Quality Engineer (Fixed Term 18 months) to join the Quality Engineering team. You will lead quality activities across development, validation, and lifecycle processes, ensuring compliance with FDA, ISO 13485, and MDR standards.

You will collaborate with cross-functional groups to drive CAPA, supplier quality, and design control efforts while mentoring junior engineers and maintaining rigorous documentation.