Tijuana - Engineer II, Quality
hace 1 mes
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
RESPONSABILIDADES:
1. Respetar y adherirse a la misión y comportamientos fundamentales de Greatbatch.
2. Adherirse a todos los requerimientos de seguridad industrial y calidad.
3. Responsable de coordinar el proceso del plan de validación, así como crear, revisar y/o aprobar documentación relacionada con cambios requeridos en su celda de trabajo (ECO, Validaciones, Estudios de Ingeniería, QCI, QWI, Métodos de Prueba, etc.).
4. Responsable de dar seguimiento a actividades de manejo de riesgo, FMEA,s y planes de control.
5. Coordinar las actividades de calidad relacionadas con la ejecución de protocolos (PQ’s), pruebas de validación y proyectos especiales con sus inspectores de calidad.
6. Desarrollar y conducir los experimentos y/o estudios estadísticos diseñados para determinar las fuentes de variación de los procesos para mantener o mejorar la calidad del producto.
7. Monitorear y administrar los indicadores de calidad de su celda asegurando que sean cumplidos en tiempo y forma (CAPAS, NCMR, Quejas de Cliente, RMA, Cuarentena, Adherencia al plan de manejo de riesgo, etc.), además de dar soporte para lograr los indicadores de su celda.
8. Conducir la investigación, documentación e implementación de acciones correctivas para tratar noconformidades del proceso y brinda soporte a quejas del cliente.
9. Dar soporte a ingeniería de calidad de clientes en actividades requeridas por el cliente.
10. Participar y facilitar auditorías externas ó internas.
11. Proporcionar enseñanza técnica a sus inspectores y técnicos de calidad, además de manejar requerimientos especiales relacionados con ingeniería de calidad.
12. Supervisar a los técnicos de calidad e inspectores a su cargo en los diferentes turnos en que opere el área a su cargo, además de coordinar sus actividades diarias (vacaciones, permisos y necesidades de desarrollo y capacitación).
13. Realizar otras funciones según se requiera
REQUISITOS:
- Educación Mínima : Licenciatura en Ingeniería (Electromecánico, Químico o Bioquímico, Químico Industrial, Industrial, Electrónico, ó grado equivalente).
- Experiencia Mínima : Antigüedad mínima de 2 años como Ingeniero de Calidad Jr. (si aplica) o mínimo 3 años de experiencia en el ambiente técnico
- Mínimo 1 año de experiencia en el ambiente de manufactura de componentes médicos
Conocimiento Especializado :
Certificación ASQ como CQE (Ingeniero de Calidad Certificado) o Six Sigma Green Belt (Deseable) Conocimiento en los requisitos y documentación del Sistema de Calidad ISO 13485, conocimiento del QSR y GMP’s. Conocimiento computacional: Minitab, VISIO, Oracle, Microsoft Office.Inglés nivel avanzado.
▪ Habilidad para redactar descripción de problemas.
▪ Habilidad para escribir documentos técnicos.
▪ Habilidades de análisis.
Competencias Humanísticas :
Seguridad. Calidad en el trabajo. Trabajo en equipo. Proactivo. Comunicador efectivo. Servicio al cliente. Solución de problemas. Pensamiento innovador. Orientado por el detalle. Liderazgo. Delegación. Desarrollo de personas. Toma de decisionesU.S. Applicants: EOE/AA Disability/Veteran
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