Quality Engineer I - MedTech QA & Compliance

Johnson & Johnson MedTech; Ciudad Juárez; Presencial; MXN 279.000 - 469.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech is seeking a Quality Engineer II for our Horizontes Plant in Ciudad Juarez, Mexico. The role focuses on applying quality engineering tools across the product lifecycle to improve transfers and maintain processes.

The ideal candidate will have a engineering degree and up to 2 years of experience, with strong problem-solving skills, proficiency in English, and familiarity with GMP, QSRs and ISO 13485 standards.

Formación

• Bachelor’s in engineering: Mechanical, Electrical, Industrial or applicable science.
• 0 to 2 years of work experience or demonstrated performance.
• Statistics knowledge.
• Use of computer packages.
• Ability to communicate in English, orally and in writing.
• Knowledge of engineering fundaments.
• Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.
• Active involvement in problem solving and resolution, highly desired.
• CQA certification (preferably).

Responsabilidades

• Revision / analysis of the effectiveness of PCDA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.
• Revises / analyzes if current products and processes comply with regulations (QSRs, ISO 13485) and supports audits.
• Interacts with regulatory agencies (FDA, JJRC, BSI).
• Responds to audit observations related to quality engineering.
• Maintains documentation of quality assurance activities and systems.
• Performs periodic audits of the line for GMPs and process controls.
• Supports investigations and CAPAs related to non-conformities and customer complaints.
• Analyzes product-related customer complaints to determine failure modes.

Conocimientos

Statistics knowledge

English communication

Quality mindset

Problem solving

Active involvement in problem solving

Educación

Bachelor’s in engineering

Herramientas

QMS

Descripción del empleo

Johnson & Johnson MedTech is seeking a Quality Engineer II for our Horizontes Plant in Ciudad Juarez, Mexico. The role focuses on applying quality engineering tools across the product lifecycle to improve transfers and maintain processes.

The ideal candidate will have a engineering degree and up to 2 years of experience, with strong problem-solving skills, proficiency in English, and familiarity with GMP, QSRs and ISO 13485 standards.