5+ years of work experience in the Medical Device industry in Design Qualityrole

Understanding on Medical Device Quality and Compliance

Knowledge on ISO 13485: 2019 and 21 CR 820

Experience in Complaints Handling, Post Market Surveillance

Knowledge on Medical Device Regulatory Standards, MDD and MDR

Knowledge on NC, CAPA, Audit processes

Medical Devices Risk Management. Can also identify less obvious risks in a given business opportunity.

Experience with Application, Process, Design and System FMEA etc.

Able to adapt to changing/emerging data requests from a variety of different system applications.

Experience with statistical tools and techniques including DOE. Able to perform advanced descriptive and non-parametric statistical analyses.

Can translate stressors into an executable testthat accurately predicts field reliability; able to use advanced statistics forprediction

Experience...