Quality Engineer (Medical Devices)

Descripción y detalle de las actividades- Develop quality tests, develop documentation, and test procedures, keep track of ISO 13485 quality standards, and FDA 21CFR requirements. - Familiar with standard quality system indicators such as CCs, NCMRs & CAPAs. - Ability to manage NPIs and continuous improvement project activities (Validation Protocols & Test Method Validations). -Ensure compliance with quality systems (ISO 13485, FDA QSR) during production processes. - Execute the CAPA tools (Corrective and Preventive Action) as required both internally and externally, to generate the desired changes and continuous improvement. -Represent Quality on various teams, including ISO and/or FDA audits, providing data insights as needed, including internal audits.Experiência y requisitos- Fluent english is required. -Experience in the medical device industry > = 4 years. - High efficient communication skills to handle customer relationship and different leadership levels.OrganizaciónFoxconn Baja California, S.A. de C.V.GiroMaquiladora (Export.)Actividad principalElectrónica.Número de empleados45000**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Estudios** Titulo Profesional**Sexo** Indistinto