Descripción y detalle de las actividadesEnsure compliance the Rogers Foam Quality System Develop and maintain procedures, work instructions and records that meet the requirements of the quality system ISO 13485: 2016, ISO 9001: 2015 and 21CFR part 820 Generate and ensure reports and correct follow-up to corrective and / or preventive actions derived from CAPAs, internal or external audit actions, NCMRs and customer complaints Respond and follow up on customer complaints according to the established procedure Carry out and follow up on internal audits according to the established procedure Responsible for the document control process and label area according to established procedures. Responsible for the receipt inspection process according to the established procedure Responsible for generating and monitoring the closing of SCARs with suppliers Participate in external audits Coordinate and control the area of non-conforming material, MRB Inspection and release of first articles according to the established procedure Review and release fixtures, gages, templates, etc. that will be used in the manufacturing process Support and exercise leadership in root cause investigation activities Carry out a statistical analysis for the applicable process when necessary Participate in validation activities, review and approve protocols and reports of IQ, OQ, PQ, Engineering Studies and TMV Generate and approve documents related to risk analysis, FMEA. Supervise Quality Inspectors and / or Technicians and provide support in any activity required in the manufacturing areasExperiência y requisitosBachelor's degree in Industrial, Systems or Mechanical engineering At least 2 years experIence in similar position English 85% (written and spoken)OrganizaciónRogers Foam TijuanaGiroManufactureraActividad principalManufactura de componentes y posicionadores médicos elaborados en base a hule espuma (foam)Número de empleados670**Área** Calidad**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** 6,30PM-6.30AM, LUN-JUE**Estudios** Titulo Profesional**Inglés **Hablado: 85%, Escrito: 85%**Sexo** Indistinto