Senior Quality Engineer - MedTech & Cardio Quality Leader

jj; Ciudad Juárez; On-site; MXN 480,000 - 600,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Engineer (Fixed Term 18 months) for Planta Salvarcar, Ciudad Juarez. The role focuses on leading quality engineering across new products and processes, ensuring design verification tests, process validations, and compliance with MDR, FDA, ISO 13485, and QMS standards.

Responsibilities include supervising quality activities, CAPA initiation, and collaboration with cross-functional teams to drive product quality throughout the lifecycle.

Qualifications

• Bachelor's degree in a related field and 4–6 years of quality, manufacturing, or R&D experience in a medical device or regulated industry; Master’s degree preferred.
• ASQ certification and Six Sigma experience desirable.
• GD&T knowledge desirable.
• Ability to develop and implement quality standards and procedures.
• Thorough knowledge of GMP and QSR requirements for medical devices.

Responsibilities

• Lead quality engineering activities for new products and processes.
• Use QA tools to develop transfer and maintenance of products/processes across the lifecycle.
• Lead CAPA investigations and supplier quality activities as needed.
• Support design reviews, risk management, and verification/validation activities.
• Ensure compliance with MDR, FDA, ISO 13485 and related regulatory requirements.

Skills

Quality Engineering

Six Sigma

CAPA

GMP

Auditing

Education

Bachelor's degree in related field

Master's degree preferred

Tools

QMS

Job description

Johnson & Johnson is seeking a Senior Quality Engineer (Fixed Term 18 months) for Planta Salvarcar, Ciudad Juarez. The role focuses on leading quality engineering across new products and processes, ensuring design verification tests, process validations, and compliance with MDR, FDA, ISO 13485, and QMS standards.

Responsibilities include supervising quality activities, CAPA initiation, and collaboration with cross-functional teams to drive product quality throughout the lifecycle.