**Descripción y detalle de las actividades**- The Quality Superintendent would be responsible for assuring the implementation and maintenance of a Quality Management system in the Tecate Facility. Assist regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established. Provide training and guidance to ISO 13485. Coordinate and participate in elements of investigation regarding customer complaints. Routinely review regular inspection data and prepare statistical and operational performance reports. Work with engineering team to produce protocol and process validation procedures in accordance with quality guides. Perform internal audits to assess compliance to Standards and to the Internal Quality system, including Investigation, presentation of observations and findings and reporting. Provides Quality control Leadership to Manufacturing area. Assessment of system to identify deficiencies and participate in resolutions of issues found. Review and verify procedures developed for the Calibration and Control of equipment. Provides Quality control Leadership to Manufacturing area.**Experiência y requisitos**- Bachelor's degree in Engineering or related field. - Five years of Experience in the Quality/regulatory field with a medical device firm, highly desirable. Experience as an active participant in regulatory ,FDA ,ISO or compliance agency audits. 5-10 Years of experience in manufacturing environment. Demonstrated ability to establish and maintain an effective working relationship with subordinates, peers and all levels of management, to work in a team atmosphere and to meet quality and Production goals, required. Bilingual, English/Spanish.**Organización**- Westmed de México, S.A. de C.V.**Correo de contacto**-- copiar**Giro**- Maquiladora (Export.)**Actividad principal**- Productos médicos.**Número de empleados**- 600**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** Lunes a viernes de 06:30 am a 04:06 pm**Estudios** Carrera Profesional**Sexo** Indistinto**Edad** 39 - 50 años