Sr Quality Applications Spec

Descripción del Empleo:
Writes procedures, protocols and any other documentation needed for the enhancement of systems. Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. Drives SPC or preventive action methods.
Requisitos:
BD in Natural Science, Engineering or Science of Engineering
5+ years of experience
Fluency speaking and writing in English and Spanish
Experience in medical device, pharmaceutical, or electronic industry
Experience in reviews and approves qualification / validation reports, process changes, quality records or manufacturing documentation.