Responsible for maintaining the local Quality Assurance system of Boston Scientific in Chile. Among the responsibilities are: - Create and keep updated the local standard operating procedures - Monitoring and implementation of CAPA Plans - Coordinate the tasks of the Quality Assurance staff and supervise the fulfillment of assignments. - Attend and represent the organization in internal and external audits- Carry out and coordinate staff training- Manage of Field Actions and recall activities- Develop, update and maintaining of Quality Agreements.- Reporting security information to local health authorities and headquarters - Respond to the requirements of the health authorities - Follow up safety cases - Reception, reporting and investigation of cases related to quality complaints of medical devices- Verify quality compliance for the imported products. Release products according to regulations - Update and maintain procedure and instructions- Maintain documents records- Approve the release to market of products from imports and returns from customers- To represent the quality area and to present results in Management review - Supplier evaluation and audit- Supervise compliance with local regulation and internal requirements of service providers.- Define product disposition in case of temperature deviations

Responsable de coordinar y ejecutar las actividades de aseguramiento de calidad del laboratorio, incluyendo auditorías internas y externas, planes CAPA, controles de cambio, desvíos, manejo de quejas, validaciones, calificaciones, capacitaciones, ejecución y seguimiento de programas, etc.

Responsible for maintaining the Pharmacovigilance system in Chile with internal and external requirements by distributors in South, Central and North América. Pharmacovigilance system maintenance includes:-Sending security information to local health authorities and central offices-Respond to the requirements of health authorities-To perform and submit periodic safety reports and risk management plans.-Follow up safety cases- Carry out Pharmacovigilance audits to distributors and third party collaborators- Control the development of Patient Support Programs- Conduct Pharmacovigilance training for company employees and those responsible for the area of external distributors- Create and keep updated the standard operating procedures of the area- Monitoring and implementation of CAPA Plans - Periodic review of scientific literature and regulatory platforms

Responsible for maintaining the Pharmacovigilance system in Chile and Peru and supervising compliance with internal and external requirements by distributors in Bolivia, Ecuador, Paraguay and Uruguay. The maintenance of the Pharmacovigilance system includes:- Sending safety information to local health authorities and headquarters- Respond to the requirements of the health authorities- Present periodic safety reports and risk management plans- Follow up safety cases- Reception, reporting and investigation of cases related to quality complaints of pharmaceutical products- Carry out pharmacovigilance audits for distributors and third-party collaborators- Control the development of Patient Support Programs- Carry out pharmacovigilance trainings for company employees and those responsible for the area of ​​external distributors- Create and keep updated the standard operating procedures of the area- Collaborate with the Laboratory Quality Assurance area in the management of deviations and change control- Monitoring and implementation of CAPA Plans

-Recepción, investigación y reportes de RAM-Desarrollo de IPS y PMR-Investigación de quejas y reclamos