Quality Assurance Specialist

Descripción y detalle de las actividades- Part of the DCU working in Global and multicultural Team that assures customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements. To provide input, carry on Global Projects and improvements related to complaint handling processes. To be a key contact person for stakeholders and ensures that Global complaint process inspections and Audits (internal and external) are prepared and covered on local market. - Be a key contact person to local Customer Service, Affiliates, LPoC to ensure correct information intake and day to day work. Be responsible for local Audits / FDA Inspection as planned. Lead assigned Global/Local complaint processes and projects. - Perform follow ups with investigators/LPoC/others to ensure complaints are processed in a timely manner. Continuously review complaint files to ensure documentation is performed according to requirements (internal/external) and in line with GDP needs. - Perform initial screening of new complaints to determine potential reportability, investigator and appropriate investigation location.Experiência y requisitosWorking experience in complaint handling and customer quality required. Knowledge of Operational processes. Experience in complaint handling processes for medical devices. Knowledge of FDA regulations, ISO13485. Ability to actively participate and present during External/internal Audits, FDA Inspections.**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Carrera Profesional**Inglés **Hablado: 90%, Escrito: 90%**Sexo** Indistinto**Disponibilidad p. viajar** Si