Quality Systems Engineer
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Descripción del puesto
Como Quality Systems Engineer, tu puesto se centrará en diseñar, mantener y mejorar el sistema de gestión de calidad de la empresa para garantizar el cumplimiento de normas internas y regulaciones externas. En tu día a día, revisarás y actualizarás procedimientos, apoyarás auditorías internas y externas, analizarás datos de calidad y coordinarás acciones correctivas y preventivas con los equipos de ingeniería y producción. También colaborarás en proyectos de mejora continua, participarás en la validación de procesos y asegurarás la correcta documentación según requisitos ISO 13485 y FDA. Es un puesto de tiempo completo, mayormente presencial en nuestras instalaciones. Requisitos
• Aptitudes sólidas en sistemas de calidad, incluyendo experiencia en Quality System y Quality Management para entorno de dispositivos médicos.
• Capacidad demostrada en Quality Assurance, asegurando el cumplimiento de procedimientos, normas ISO 13485 y requisitos FDA.
• Experiencia en Quality Auditing y Auditing, tanto en auditorías internas como en el soporte a auditorías externas y de clientes.
• Titulación universitaria en Ingeniería, o similar; se valora formación específica en gestión de calidad.
• Conocimiento de herramientas de mejora continua (Lean, Six Sigma), análisis estadístico y manejo de sistemas de documentación electrónica.
• Aptitudes de comunicación, trabajo en equipo, organización y atención al detalle; capacidad para colaborar con producción, ingeniería y calidad.
• Nivel competente de inglés para lectura de normas, documentación técnica y comunicación con equipos internacionales.
• Experiencia laboral en esta posición con al menos 5 años de experiencia.
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