Complaint Specialist

Descripción y detalle de las actividadesUsing working knowledge and understanding of the US FDA regulations for medical devices and complaint handling and reporting, the Complaint Specialist ensure complaint investigations are adequate, accurate, detailed and timely. Duties include execution of all quality-related activities. This includes but is not limited to Quality System; Quality Engineering functions; Customer Complaints/Notifications System and Documentation Control activities associated with Quality Management System requirements. Responsible for ongoing adherence to external regulations as required by FDA's GMP, ISO 13485 and MDSAP. Creates, reviews and approves documentation changes as required.Experiência y requisitos- Engineering degree - 2 years related work experience in Quality Complaints - Computer literate (Microsoft office). - Work experience in the following fields: -Analysis of failures and analyzes to develop corrective action through the continuous improvement process. -Problem solving resolution by means of route cause/problem solving analysis (5whys, 8Ds, Ishikawa, DMAIC). -NCR's handling. -CAPA system.OrganizaciónDemant Operations, S.A. de C.V.GiroManufactureraActividad principalManufactura de aparatos auditivosNúmero de empleados400/**Área** Control de Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** Lunes a Jueves de 7am a 5:20pm y Viernes de 7am a 3pm**Estudios** Titulo Profesional**Inglés **Hablado: 85%, Escrito: 85%**Sexo** Indistinto