Sterilization Engineer

hace 4 semanas

Tijuana, México Integer Holdings Corporation A tiempo completo
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

CONTROL MEDIO-AMBIENTAL: Responsable de preparar, controlar y disponer de los materiales necesarios para llevar a cabo el monitoreo medio-ambiental en cumplimiento con el Sistema de Calidad, ISO 13485, la Directiva Médica Europea (MDD)-FDA/QSR así como requerimientos locales y corporativos.

  • Responsable de coordinar las actividades de Control Medio-Ambiental en la planta.
  • Responsable de iniciar la investigación medio-ambiental en caso de exceder los límites de alerta y acción, emitiendo opinión técnica de la causa de falla y establecer acciones preventivas y correctivas y su despliegue de acuerdo con los procedimientos.
  • Responsable de emitir mensualmente un reporte de evaluación medio-ambiental para las unidades de Negocios para la revisión administrativa del Sistema de Calidad, la Junta de Acción Correctiva (CAB), Reporte a Calidad.
  • Responsable del análisis Químico y Microbiolٖógico y Control el Procesamiento de Agua.

CONTROL DE ESTERILIZACIÓN

  • Responsable de la liberación final del producto de manufactura estéril en cumplimiento con los requerimientos del Sistema de Calidad ISO 13485, la Directiva Médica Europea (MDD)-FDA /QSR, así como requerimientos locales y del corporativo.
  • Responsable del controlar el proceso y archivo de los registros de esterilización.
  • Responsable de emitir las liberaciones del Reporte de esterilización.
  • Responsable de la coordinación y manufactura interna y de muestras de producto requeridas para validaciones y/o estudios medio-ambientales.
  • Responsable de mantener el control del envío de muestras que necesita ser procesado en centros de esterilización para poder realizar las validaciones correspondientes y renovaciones.
  • Responsable de mantener el control en la esterilización final de las validaciones y reportes de re-validaciones.
  • Responsable de mantener los documentos que aplican para procesos de esterilización.
  • Responsable del control de inconformidades e incidentes de los centros de esterilización.

AUDITORÍA DE CALIDAD DOSIS (DQA)- Si se requiere por el proceso:

  • Control, verificación y cumplimiento y mantenimiento trimestral del Programa Auditorias de Calidad de Dosis (DQA) para procesos de esterilización y radiación.
  • Coordinar la preparación de las muestras que se necesitan [ara Programa Trimestral de Auditorias de Calidad de Dosis (DQA) en coordinación con Planeación, Producción, y el Proceso de Control de Calidad.
  • Coordinar el envío de muestras trimestrales del Programa Auditorias de Calidad de Dosis (DQA) al respectivo laboratorio de prueba.
  • Mantener control de los archivos, registros, y archivos de las Auditorias de Calidad de Dosis (DQA) de manera trimestral.

PROGRAMA DE CONTROL DE CARGA BIOLOGICA (Bioburden)

  • Control, verificación y mantenimiento del cumplimiento con el Programa de Control de Carga Biológica, verificación de la radiación y esterilización de procesos
  • Coordinar la preparación de muestras que se necesitan para el Programa de Control de Carga Biológica en coordinación con Planeación, Producción, y Procesos de Control de Calidad.
  • Coordinar el envío de las muestras para verificación del Programa del Laboratorio Biológico hacia el respectivo Laboratorio de prueba.
  • Mantener control de los archivos y registros del Programa de Carga Biológica.

PREPARACION DE ESPORAS.

  • Si se requiere por el proceso:
  • Responsable de la administración y control de esporas.
  • Responsable de la preparación/ inoculación/ esporulación de los productos de acuerdo a las validaciones de los requerimientos, re-validaciones o evaluaciones de las cámaras y el ciclo de esterilización por óxido de etileno
  • Coordina el envío de muestras para el Programa Anual de validaciones, re-validaciones o evaluación de las cámaras de ciclo, y la esterilización del óxido de etileno ETO hacia el Centro de esterilización respectivo.

RESPONSABILIDADES ADICIONALES.

  • Control del envío de muestras especiales como: Muestras de Validación para evaluar los efectos del proceso de esterilización- Evaluación del residuo de óxido de etileno – ETOR – Realización o preparación y sumisión de muestras de prueba de Pyrogen / Control de endotoxina – Revisión e inspección de Centros de Esterilización y Centros de Distribución.

U.S. Applicants: EOE/AA Disability/Veteran

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