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qlty & reliability engineer ii

hace 2 meses

San Francisco, Heredia, Costa Rica TE Connectivity A tiempo completo

QLTY & RELIABILITY ENGINEER II

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

El Ingeniero de Calidad 1 es responsable de garantizar que todos los productos y procesos en la organización cumplan con los estándares de calidad establecidos, así como con los requisitos regulatorios aplicables a la industria. Este papel implica la implementación de sistemas de gestión de calidad, la realización de auditorías internas y externas, la gestión de no conformidades, y la colaboración estrecha con los equipos de manufactura y operaciones para asegurar la excelencia en la calidad del producto final. El objetivo del puesto es contribuir al desarrollo y mejora continua de los procesos de fabricación y control de calidad de productos médicos que cumplan o excedan las expectativas de los clientes y los reguladores, garantizando la seguridad y eficacia de los productos.

What your background should look like:

Responsabilidades :


• Desarrollar e implementar procesos de clase mundial en el Sistema de Calidad, en apoyo de los requisitos del negocio, trabajando estrechamente con los líderes de Calidad del sitio.


• Asegurar que tanto los protocolos de validación como sus reportes cumplan con la información requerida en los procedimientos y las evidencias obtenidas hagan sentido con la documentación.


• Realizar, en caso de ser requerido, análisis estadísticos de capacidad, normalidad, igual de varianzas o medias, entre otros.


• Crear, modificar y revisar formularios de inspección en proceso e inspección final.


• Revisar instrucciones de producción, inspección, estándares visuales, entre otros y acoplarlos al sistema de calidad local.


• Dar seguimiento y ejecutar change plans en el sistema de SmartSolve para cambios de tipo documental y ERP, que se relacionen con procesos de Validación.


• Dar seguimiento al estatus de los documentos de transferencia y validaciones creados.


• Participar en conversaciones con representantes de calidad, ingeniería, producción.


• Asegurar la aplicabilidad de las políticas, procedimientos y objetivos actuales de calidad.


• Planificar y ejecutar proyectos y actividades de equipo para facilitar los cambios en el sistema de calidad.


• Crear y revisar la documentación del sistema de calidad.


• Realizar capacitaciones en el sitio, cuando sea necesario.


• Implementar y mantener sistemas de gestión de calidad conforme a las normativas ISO 13485, FDA QSR, y otras aplicables en la industria médica.


• Realizar auditorías internas y preparar a la empresa para auditorías externas por parte de organismos reguladores y clientes.


• Trabajar en conjunto con equipos de desarrollo de productos y manufactura para asegurar la calidad desde la concepción del producto hasta su lanzamiento al mercado.


• Investigar, analizar y resolver problemas de calidad, implementando acciones correctivas y preventivas efectivas.


• Gestionar la documentación y registros de calidad, asegurando su integridad y cumplimiento regulatorio.


• Participar en la validación de procesos y equipos, incluyendo la elaboración de protocolos, la ejecución de pruebas y la redacción de informes de validación.


• Contribuir a la formación y concientización sobre calidad dentro de la organización.


• Monitorear indicadores de calidad y presentar informes periódicos sobre el desempeño de calidad a la dirección.

Educación


• Licenciatura o bachillerato con énfasis en ciencias o ingeniería.


• Título que le acredite para el desempeño del puesto en áreas de Ingeniería o una disciplina equivalente.


• Certificación CQE/CSSBB deseable.

Requerimientos :


• 1 año de experiencia mínima en puestos similares.


• Experiencia en liderazgo de calidad trabajando en un entorno de fabricación, idealmente en un entorno multinacional.Experiencia previa trabajando en dispositivos médicos u otro entorno regulado por la FDA


• Nivel de inglés al menos C1, comunicación constante con Clientes y el Corporativo

Habilidades :


• Excelente comunicación y habilidades interpersonales.
• Altamente organizado con gran capacidad para priorizar tareas y trabajar por iniciativa.
• Capacidad para evaluar la información recopilada a partir de la observación, la experiencia, el razonamiento y / o la comunicación.
• Excelente atención al detalle y redacción de informes.
• Posibilidad de flexibilizar los horarios de trabajo y disposición a viajar según sea necesario (hasta un 10%).
• Habilidades analíticas y de resolución de problemas.
• Capacidad para trabajar en equipo y colaborar efectivamente con diferentes departamentos.
• Dominio de herramientas informáticas relacionadas con la gestión de calidad y análisis de datos.

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

Location:

Heredia, H, CR, 14650

City: Heredia

State: H

Country/Region: CR

Travel: Less than 10%

Requisition ID: 122451

Alternative Locations:

Function: Engineering & Technology

TE Connectivity and its subsidiaries, affiliates, and operating units (collectively, the "Company") is committed to providing a work environment that prohibits discrimination on the basis of age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation.