Senior Quality Engineer - MedTech & Regulatory Compliance

Johnson Johnson; Ciudad Juárez; On-site; MXN 520,000 - 860,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Senior Quality Engineer for a fixed-term 18-month assignment at Planta Salvarcar in Ciudad Juarez. You will drive quality engineering activities across new product development and production, ensuring compliance with FDA, ISO 13485 and other global standards.

Responsibilities include design control, risk management, CAPA, process validations, and collaboration with regulatory and operations teams to ensure robust product quality throughout the lifecycle.

Qualifications

• Bachelor's degree in a related field; minimum 4–6 years of quality/manufacturing/R&D in medical devices or similar regulated industry.
• Experience with regulatory requirements (FDA, ISO 13485, CMDCAS, PMDA) and design control.

Responsibilities

• Lead quality engineering activities to support new product development and lifecycle management.
• Develop and validate processes, protocols, and reports for product and process verification and validation.
• Perform CAPA investigations and drive corrective actions across cross-functional teams.
• Collaborate with Regulatory Affairs to support submissions for process changes and new devices.
• Mentor and guide junior engineers and supervise inspectors/technicians as needed.

Skills

Quality Engineering

GMP & QSR

Six Sigma

Process Excellence

Auditing

GD&T

Project Management

Problem Solving

Education

Bachelor's degree in a related field

Master's degree preferred

Job description

Johnson & Johnson MedTech is seeking a Senior Quality Engineer for a fixed-term 18-month assignment at Planta Salvarcar in Ciudad Juarez. You will drive quality engineering activities across new product development and production, ensuring compliance with FDA, ISO 13485 and other global standards.

Responsibilities include design control, risk management, CAPA, process validations, and collaboration with regulatory and operations teams to ensure robust product quality throughout the lifecycle.