Lead Quality Assurance Engineer

2 weeks ago

Sturtevant, Wisconsin, United States Cirtec Medical Corporation Full time
Descripción del Trabajo

RESUMEN DEL PUESTO
El Ingeniero de Calidad Senior será responsable de desarrollar, establecer y mantener metodologías, sistemas y prácticas de ingeniería de calidad que cumplan con los requisitos del cliente y las normativas. Este rol se centrará en proporcionar apoyo de ingeniería de calidad al proceso de desarrollo de nuevos productos, operaciones/producción y sistemas de calidad. Además, esta persona actuará como representante de Calidad para mejorar la conciencia, visibilidad y comunicación sobre las iniciativas de calidad que apoyan los objetivos y prioridades de calidad del sitio y de la corporación.

RESPONSABILIDADES ESENCIALES

• Proporcionar apoyo de Ingeniería de Calidad para el desarrollo de productos de ingeniería o manufactura sostenida.

• Brindar apoyo en la Gestión de Proyectos de Calidad según sea necesario para las transferencias de productos desde el desarrollo hasta la validación y producción.

• Ser el propietario del Sistema de Verificación/Validación, responsable del desarrollo y gestión del plan maestro de verificación/validación, así como de la determinación de verificación/validación.

• Desarrollar y mantener Procedimientos Operativos Estándar.

• Elaborar y mantener Planes de Calidad de Proyectos para los proyectos asignados.

• Desarrollar protocolos, realizar análisis estadísticos y redactar informes para validaciones y desarrollo formal de productos/procesos, que requieren la participación de ingeniería de calidad.

• Apoyar el desarrollo e implementación de protocolos de IQ (Calificación de Instalación) y OQ (Calificación Operacional) para asegurar el cumplimiento con el Sistema de Calidad.

• Proporcionar apoyo de Ingeniería de Calidad para la ingeniería/manufactura.

• Ser propietario o apoyar el sistema CAPA (Acción Correctiva y Preventiva), responsable del apoyo del sistema de acciones correctivas y procedimientos.

• Interactuar con clientes y proveedores para resolver investigaciones de CAPA y quejas.

• Proporcionar apoyo de Calidad para la disposición de materiales a través de NCRs.

• Apoyar actividades de calidad de proveedores, incluyendo la aprobación de proveedores y el mantenimiento y evaluación de datos de rendimiento de proveedores (es decir, SCAR/a tiempo).

• Revisar y documentar cambios en procedimientos para requisitos de calidad y cumplimiento con el sistema de calidad.

• Desarrollar sistemas y procedimientos de calidad según sea necesario.

• Apoyar auditorías de terceros, auditorías de clientes y auditorías internas.

• Apoyar la implementación de iniciativas de mejora continua.

• Desarrollar y mantener planes de control de calidad de producción.

• Iniciar y mantener SPC (Control Estadístico de Procesos) para procesos de producción.

• Liderar o apoyar FMEA (Análisis de Modos y Efectos de Fallo) y DOE (Diseño de Experimentos) según sea aplicable.

• Puede servir como respaldo del Gerente de Calidad.

• Cumplir con los estándares, políticas y procedimientos de calidad y seguridad de la empresa.

• Otras tareas según se asignen.

CALIFICACIONES

• Se requiere un título de licenciatura (preferiblemente en disciplina de ingeniería STEM) y 5 años de experiencia; o una combinación de educación y experiencia laboral relevante.

• Experiencia en un entorno de ingeniería con procesos de diseño mecánico, herramientas y manufactura (preferiblemente dispositivos médicos).

• Debe ser fluido en el uso de sistemas informáticos para el análisis de datos, específicamente Microsoft Office.

• Debe poseer excelentes habilidades de comunicación verbal, organización y gestión.

• Capacitación o experiencia equivalente en el uso de computadoras y software-Microsoft Word, Excel, Power Point y Access. Experiencia en Minitab deseable.

• Debe poder leer, escribir y hablar en inglés con fluidez.

• Debe ser capaz de implementar programas de calidad, interpretar los datos recopilados y presentar los datos a la gerencia para impulsar la mejora continua.

• Debe ser capaz de analizar y procesar información; promover la Mejora de Procesos, Desarrollar Estándares, Gestionar Procesos, Métodos de Manufactura y Procedimientos; y Apoyar la Innovación.

AMBIENTE DE TRABAJO
El trabajo se realiza en un entorno de oficina. El nivel de ruido en el entorno laboral es generalmente moderado. Las características del entorno laboral descritas aquí son representativas de aquellas que un individuo encuentra al realizar las funciones esenciales de este puesto.

DECLARACIÓN DE EEO
Cirtec Medical Corporation es un Empleador de Igualdad de Oportunidades para Minorías/Mujeres/Individuos con Discapacidades/Veteranos Protegidos y de Acción Afirmativa. Cirtec Medical Corporation considera para empleo y contrata candidatos calificados sin importar la edad, raza, religión, color, sexo, orientación sexual, identidad de género, nacionalidad, ascendencia, estado de veterano protegido o discapacidad, o cualquier factor prohibido por la ley. Cirtec Medical Corporation y todas sus empresas relacionadas apoyan plenamente la igualdad de oportunidades para todos. Cirtec Medical proporciona adaptaciones razonables para individuos calificados con discapacidades y veteranos discapacitados en el proceso de solicitud de empleo.

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