Lead Supervisor, Quality Operation
hace 5 días
Objetivos de la posición:
- Lidera y supervisa al equipo de calidad, asegurando el cumplimiento de los estándares de calidad, la excelencia operativa y la integridad del producto en los procesos de manufactura y calidad. El puesto supervisa directamente las actividades de calidad en la línea de producción, impulsa la mejora continua, apoya las investigaciones de eventos y supervisa a los inspectores de calidad para garantizar un desempeño constante y la adherencia a los estándares.
Requisitos de la posición:
- Se requiere título universitario, preferiblemente en ingeniería, ciencias o áreas afines.
- Mínimo 5 años de experiencia en Aseguramiento de Calidad u Operaciones de Calidad dentro de un entorno de manufactura regulado (dispositivos médicos, farmacéuticos o similar).
- Dominio del inglés Avanzado (oral y escrito).
- Conocimiento intermedio de estadística.
- Conocimiento avanzado del paquete Microsoft Office.
- Conocimiento de regulaciones FDA, ISO 13485 y 21 CFR Parte 820 Quality System Regulation (deseable).
- Capacitación en CAPA y/o herramientas de investigación.
- Conocimiento de System Applications and Products in Data Processing (SAP).
- Comprensión de validaciones de procesos, revisión y aprobación de protocolos.
- Conocimiento de procesos de auditoría, incluyendo preparación, ejecución, soporte en backup room y auditorías.
- Familiaridad con metodologías de mejora continua (Kaizen, Lean, Six Sigma).
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