Descripción y detalle de las actividadesJob Functions - Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA. - Responsible for reviewing, approving, and releasing functional reports performed. - Manage database of the released lots and the components used on each lot to ensure traceability. - Reconciliation of released finished product and SCRAP quantities. - Ensure produced quantity of final product is aligned with customer work orders. - Transfer of DHR's using the electronic platform designated by customer. - Assign lot numbers for different manufacturing processes. - Oversee activities of QA production crew. - Assist in the coordination of QA resources for the different manufacturing processes and overtime needs. - Manage Supplier Control program and maintain ASL. - Generate Quality Agreements and Supplier Surveys. - Conduct Supplier Audits and generate reports. - Evaluate Manufacturing Deviations and support resolutions. - Conduct Internal audits and generate audit reports. - Assign, capture, and control equipment and process validation numbers as required by engineering. - Responsible for generating, maintaining, and controlling Asset Numbers, and facility Inventory Numbers. - Participates in activities related with the preparation of external audits. - Act as a SME for QA production processes and Supplier Control during external audits. - Assist in the creation of reports and charts for the Measurement of KPI's related to the quality department. - Be an active enforcer of good manufacturing practices inside and outside the quality department. - Assist in product rework activities, generating forms for the in-process and final release inspections and controls required for quality assurance.Experiência y requisitosKnowledge and Requirements - 5 years of experience in Quality Assurance - Bachelor's Degree - English level (advanced) - Knowledge of QSRs & ISO 13485:2016**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario** 7:00 am - 5:30 pm**Estudios** Carrera Profesional**Sexo** Indistinto**Disponibilidad p. viajar** No