Sterilization Engineer

hace 3 semanas

Tijuana, México Emprego MX A tiempo completo

Descripción y detalle de las actividades

Asegura que la calificación de proveedores, validaciones, revalidaciones, controles de proceso y liberación de producto terminado relacionados a los procesos de esterilización se lleven acabo y cumplan con los requerimientos establecidos en las regulaciones y normas aplicables.

Experiência y requisitos

Inglés avanzado Conocimientos avanzados en ingeniería de calidad: Manejo de producto no conforme, Control de procesos MFG/ Manejo de producto terminado/Análisis de datos y monitoreo Conocimientos avanzados en sistemas de calidad (ISO 13485-2016 MDSAP, FDA-QSR’s, EU MDR, CANADA): Manejo de CAPA/SCAR Auditorías Internas y Externas Control proveedores" Herramientas de investigación de causa raíz avanzadas (Metodología 8D’s, DMAIC, etc.) y solución de problemas Herramientas estadística avanzada (Indice de capacidad de procesos, Diseño de experimentos, ANOVA, análisis de probabilidad y distribución). Herramientas de mejora continua (Lean Manufacturing / Six Sigma). Conocimiento en procesos de esterilización (Gamma ISO 11137 / EO ISO 11135) Conocimiento en sistemas de validaciones (MVP / Mantenimiento estado validado) Uso avanzado de herramientas de análisis de riesgo Conocimiento en pruebas microbiológicas Conocimiento en controles, monitoreo y validación de áreas de ambiente controlado (ISO 14644 / NOM-241)

Organización

Mediméxico, S. de R.L. de C.V

Giro

Maquiladora (Export.)

Actividad principal

Somos empresa lider en la manufactura de productos médicos.

Número de empleados

3000

/**Área** Calidad

**Contrato** Permanente

**Turno** Diurno

**Jornada** Tiempo Completo

**Estudios** Carrera Profesional

**Sexo** Indistinto

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