Must possess 5 years of experience with br Oversight of ISO and FDA compliance standards ISO13485, 21CFR820, and advance medical device directives 90385EECbr Performing failure analysis and investigationbr DMAIC and other Six Sigma Toolsbr FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems audits.br Coordinating CAPAs, detailed investigations and implemented corrective actionsbr Leading supplier qualification activities, component qualification, supplier change requests SCRbr Supporting manufacturing line transfersvalidations IQOQPQ for multiple productsbr Risk management per ISO14971

Categories: eb3

0 Comments

Leave a Reply

Avatar placeholder

Your email address will not be published. Required fields are marked *