Senior Quality Systems Engineer | MedTech Innovation

Johnson & Johnson MedTech; Ciudad Juárez; Presencial; MXN 350.000 - 550.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech in Juarez, Mexico, seeks a Staff Quality Engineer to lead quality initiatives across multiple projects in the Salvarcar Plant. You will drive Six Sigma, risk management, and GMP compliance, collaborating with cross-functional teams to ensure robust product quality throughout the lifecycle.

The role requires strong data analysis, extensive experience in QA methods, and proficiency in English.

Formación

• As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science.
• 6 to 8 years of work experience or demonstrated performance
• Data Analysis
• Problem Solving
• Use of computer packages.
• Ability to communicate in English, orally and written.
• Knowledge of product / process Risk Management (FDA and ISO regulations), preferably.
• Advanced technical training and experience in the use of Statistics and Lean methodologies and Six Sigma, including Measuring System Analysis, SPC, DOEs, reliability, etc.

Responsabilidades

• Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
• Performs benchmarking to develop more effective methods to improve quality.
• Establishes the metrics that are the quality indicators.
• Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product.
• Revises and approves the engineering change orders. (ECOs).
• Establishes the categories of the quality costs and bases of the quality cost
• Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc, including providing support during internal and external audits.
• Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc).
• Responds to internal or external audit observations related to the function of quality engineering.
• Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
• Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS.

Conocimientos

Data Analysis

Problem Solving

English communication

Risk Management (FDA/ISO)

Lean Six Sigma

Statistics

Minitab/Statistical software

Educación

Bachelor's degree in engineering or related field

Herramientas

Statistics software

Quality management software

Descripción del empleo

Johnson & Johnson MedTech in Juarez, Mexico, seeks a Staff Quality Engineer to lead quality initiatives across multiple projects in the Salvarcar Plant. You will drive Six Sigma, risk management, and GMP compliance, collaborating with cross-functional teams to ensure robust product quality throughout the lifecycle.

The role requires strong data analysis, extensive experience in QA methods, and proficiency in English.