Quality Engineer Iii
hace 2 meses
Descripción y detalle de las actividades
Coordinates subordinates in the inspection and/or receiving testing and/or process and finished products, according to established procedures. Job Responsibilities: Participates/Leads CAPA investigations. Evaluate and makes analysis of samples received from customers related to Customer Complaints. Perform investigations and action plans related to the customer complaints and CAPAs. Works with a multidisciplinary team to identify the root cause of problems, define the necessary actions required to assure corrective and preventative actions are properly implemented and documented. Ensure that Corrective and Preventive Actions implemented have been effectives. Participate in the process and product improvement plans. Participates actively in cost reduction and PPI projects. Gives support to Quality Assurance & Quality Manager to participate in external audits and support in audit observations (ISO 9001 and ISO 13485 environment) Coordinates the initiation and closure of internal non conformances (NCMs). Uses of Trackwise System for this process. Works in the Root Cause Analysis for NCM in the production area. Participates/Leads internal audits. May participate in the Management Review as presenter on its area. Conducts trend analysis and post activities related when a trend is presented. Originator of Document and Change Control DCOs, ECOs, ECR etc. Uses of Agile System Originator of Deviations if need it using Trackwise System. Close relationship with the Quality Supervisor for activities related to product requirements. Create/perform pFMEAs and updates as needed (ISO 14971). Develop quality requirements based on drawing and customer requirements. As need it, will create or update work instructions WIN, procedures SOP, visual aids, FRM, formats, Internal Quality Alerts related to its area. Create Protocols and perform Test Method Validations, process validations quality matter. Works to achieve Quality KPEs and Quality Objectives. Participates/Leads new projects. Other duties may be assigned, as required.
Experiência y requisitos
Organización
Thermo Fisher Scientific (Planta Tijuana)
Correo de contacto
Giro
Maquiladora (Export.)
Actividad principal
Manufactura, empaque de artículos médicos desechables y moldeo por inyección.
Número de empleados
1800
**Área** Producción/Manufactura
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Titulo Profesional
**Inglés **Hablado: 90%, Escrito: 90%
**Sexo** Indistinto
**Edad** 18 - 55 años
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