Correo de contacto
Ensamble de sensores para oximetros (productos médicos).
Número de empleados
Sitio Web corporativo
Aviso de privacidad
Descripción y detalle de las actividades
-Supervise activities in Documents Control, including Quality Record retention process; -Analyze the document control processes in Mexico facilities and develop solutions for process improvement as required; -Assist internal users in the generation of change orders for documents as required, including the approval of assigned Engineering Change order as member of Document Control Engineering-Mexico signoff. -Has the responsibility to approve Spanish translations. -Monitor and Reports performance of the document control process -Writes and edits procedural documentation such as SOPs, SQPs, etc. upon required by management. -Support quality department and company on duties related to regulatory affairs. -Perform Quality System activities such as Internal Audits, Internal Observations and Analysis of Data.
Experiencia y requisitos
Bachelor degree in engineering (Industrial, Electronics, Mechatronics, or Translation and Interpreting) 2-5 Years of experience working in Document Control Computer skills in Microsoft Office applications including Word, Excel, Power Point. Ability to work with minimal guidance from direct supervisor. Good English and Spanish communication skills, written and oral, English 90% or higher Ability to interact with different departments. Preferred Qualifications and Experience: Experience as QMS Internal Auditor (ISO13485 preferred); Knowledge in Medical device Manufacturing, GMPs GDPs Prior experience with Agile, PLM system is preferred.
Número de vacantes 1
Jornada Tiempo Completo
Horario Monday to friday 08:00-17:30 hrs
Estudios Titulo Profesional
Inglés Hablado: 80%, Escrito: 80%