Sterility Assurance Specialist

Descripción y detalle de las actividadesSupport the implementation of Global Sterility Assurance Quality Operation program at the Avanos manufacturing sites.Provide sterilization sciences expertise and validation subject matter expertise in support of writing protocols and reports for sterilization validation / revalidations.Coordinate activities with the contract sterilizers and contract laboratories to support execution of sterilization validation / revalidations.Analyze sterilization reports in accordance with ISO/FDA/BSI requirements.Provide support to the cross functional teams for execution of sterilization activities related to special projects and new product development.Support with development and review to the global sterility assurance procedures ensuring compliance with ISO 11135, ISO 11137 and ISO 13485.Support with execution of activities for sterilization assessment for new business acquisition.Support sterility assurance training program.Experiencia y requisitosRequired Qualifications:B.S in Microbiology, Engineering, or Sciences. A minimum of 5 years of collective experience in sterilization sciences.Preferred Qualifications:Knowledge and experience with ISO Sterilization Standards, Medical device GMP's.BeneficiosBeneficios de acuerdo a la LFTNúmero de vacantes: 1Área: CalidadContrato: PermanenteModalidad: PresencialTurno: DiurnoJornada: Tiempo CompletoHorario:Tiempo completoEstudios: Carrera con título profesionalInglés: Hablado: Avanzado, Escrito: AvanzadoEspañol: Hablado: Avanzado, Escrito: AvanzadoDisponibilidad p. viajar: Si#J-18808-Ljbffr