Quality Systems Engineer Lead – MedTech

Johnson & Johnson Innovative Medicine; Ciudad Juárez; Presencial; MXN 520.000 - 820.000; Jornada completa

Descripción de la vacante

Johnson & Johnson Innovative Medicine in Ciudad Juarez, Mexico, seeks a Staff Quality Engineer to join the Salvarcar Plant. You will lead quality engineering activities across product life cycle, drive risk management, and support transfer and maintenance of processes.

The role requires 6–8 years of experience in quality engineering, knowledge of FDA/ISO regulations, and strong problem-solving skills. You will mentor junior staff and collaborate with cross-functional teams to ensure compliance

Formación

• Bachelor in engineering; Mechanical, Electrical, Industrial or applicable science.
• 6–8 years of work experience or demonstrated performance.
• Data analysis skills and problem solving.
• Ability to communicate in English, orally and written.
• Knowledge of product/process risk management (FDA and ISO), preferably.
• Advanced training in statistics, Lean methodologies and Six Sigma (MSA, SPC, DOEs, reliability).

Responsabilidades

• Revisions and analyses of PDCA, Six Sigma, Kaizen, Lean tools and related improvement programs.
• Benchmarking to develop more effective methods to improve quality.
• Establishes quality indicators and metrics for the process.
• Supports development of quality engineering and lifecycle management of products and processes.
• Revises and approves ECOs and quality documentation.
• Assesses compliance with regulators (FDA, ISO, QSRs) and supports audits.
• Performs line audits for GMP compliance and process controls.

Conocimientos

Data Analysis

Problem Solving

English Proficiency

Quality Mindset

Educación

Bachelor in Engineering (Mechanical, Electrical, Industrial)

Herramientas

Statistics

Lean Six Sigma

DOEs

Descripción del empleo

Johnson & Johnson Innovative Medicine in Ciudad Juarez, Mexico, seeks a Staff Quality Engineer to join the Salvarcar Plant. You will lead quality engineering activities across product life cycle, drive risk management, and support transfer and maintenance of processes.

The role requires 6–8 years of experience in quality engineering, knowledge of FDA/ISO regulations, and strong problem-solving skills. You will mentor junior staff and collaborate with cross-functional teams to ensure compliance