Validation Engineer

Descripción y detalle de las actividadesDesign, Develop, Execute, Document and Implement all validations related to Software, Machinery, Processes and Introduction of new products required by the plant for all Medline divisions. Always in compliance with the legal standards and regulations required to enable the sale of Medline Industries, Inc. products and establishing that the process methods are optimal for production and Quality assurance.Experiência y requisitosTechnical skills Bilingual (English - Spanish), English 85% intermediate / advanced Minimum 3 years of experience in Medical devices (preferred). Knowledge of FDA Code Federal Regulation part 11 and part 820, ISO-13485 Medical Devices Quality Management Systems standard. Knowledge of the ISO-11607 Packaging for terminally sterilized medical devices standard. Knowledge of mechanics, hydraulics, pneumatics, electricity, electronics, thermodynamics and intermediate / advanced thermoforming (Desirable). Knowledge and implementation skills in Lean Manufacturing, Quality and Problem Solving Tools, Core Tools, 6 Sigma, Project Management. Management of Adobe, Microsoft office (Project, Excel, Word, Power Point, Outlook), SAP, intermediate / advanced; Minitab, AutoCAD (desirable). Knowledge as internal quality auditor (Desirable). Interpersonal skills Teamwork, easy to interpret data, determined, proactive, results oriented, sense of urgency, leadership, people oriented, negotiation skills. Making decisions that lead to positive results according to analysis. Ability to manage different resources according to their individual capabilities, as well as their development and retention. Availability between shifts. Responsible and professional at all times. Schedule and shift availability.OrganizaciónCenturion Medical ProductsGiroMaquiladora (Export.)Actividad principalEmpresa maquiladora y empacadora de productos médicos.Número de empleados1200**Área** Ingeniería**Contrato** Permanente**Turno** Diurno**Jornada** Tiempo Completo**Horario** 7am a 4:30pm**Estudios** Titulo Profesional**Sexo** Indistinto