Sr Eng Quality Operations

Descripción y detalle de las actividades
What you'll be doing Ensure compliance with QSR part 820, ISO-13485 and other applicable regulations. Implements, monitors, improves and reports on metrics to monitor Quality performance. Ensure that the non-conforming material process is executed in accordance with established procedures and in compliance with determined metrics. Leads/oversees validation activities, IQs, TMVs, OQs, PQs, for designated areas Ensures that the validated status is maintained during any decision-making process. Leads or participates in NCR, SNCR, CAPA activities in accordance with established procedures and ensures compliance with quality objectives. Assists management and departmental staff in the implementation of statistical quality control techniques in order to improve operational efficiency and effectiveness. Responsible for the analysis of data obtained from the field to investigate and resolve issues identified through Post Market Surveillance Report. Pa...