Quality Engineer II: Medical Devices, Process & Compliance

J&J Family of Companies; Ciudad Juárez; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Ciudad Juárez seeks a Quality Assurance professional to join design verification, validation and quality system activities for medical devices. You will support new product development, sustaining projects and supplier quality, applying Six Sigma tools and risk management.

You will write validation protocols, analyze data with Statistical methods, help ensure compliance with FDA/ISO13485 and MDR requirements, and collaborate with cross-functional teams to drive product

Formación

• Bachelor’s degree in a related field with 2–4 years in quality/manufacturing in medical devices.
• Master’s degree preferred.
• ASQ certification or Six Sigma experience desirable.
• Familiarity with GD&T concepts desirable.
• Knowledge of GMP and QSR for medical devices.
• Experience in quality engineering, design control, and V&V tools.
• Strong problem solving and communication skills.

Responsabilidades

• Assist in new product development, sustaining and supplier quality projects.
• Write process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability.
• Ensure development activities follow design control requirements and MDR compliance; transfer to manufacturing.
• Provide support in quality improvement opportunities for legacy products and customer satisfaction.
• Assist in planning to ensure effective product acceptance, including inspection instructions and sampling plans.
• Support vendor audits as technical lead and Supplier Quality as Franchise Quality representative.

Conocimientos

Quality Assurance

Process Validation

Statistical Tools

Regulatory Knowledge

CAPA

Educación

Bachelor's degree

Master's degree preferred

ASQ certification

Descripción del empleo

Johnson & Johnson in Ciudad Juárez seeks a Quality Assurance professional to join design verification, validation and quality system activities for medical devices. You will support new product development, sustaining projects and supplier quality, applying Six Sigma tools and risk management.

You will write validation protocols, analyze data with Statistical methods, help ensure compliance with FDA/ISO13485 and MDR requirements, and collaborate with cross-functional teams to drive product