A Quality Engineer who is very passionate about working in a regulated medical device industry striving to make a positive difference in the quality of people's lives. Extremely innovative and result oriented professional with a strong academic background on biomedical engineering, Code of Federal Regulations (FDA), EU MDR, Medical Device Directives (MDD) and other disciplines like GDP, GMP, CAPA. Demonstrated working knowledge of Quality Management System, FDA Regulations (21 CFR PArt 21), ISO standards, Risk Management and complaint investigation.Areas of ExpertiseClass I, II and III medical devices | Document (DHF/DMR/QS) Review | DHF Reviews | Engineering Change Order Review | Process and Continuous Improvement | Design Verification & Validation | Design Controls | CAPA | Quality lead in Audit Backroom (internal/external) | DHF remediation | Non-confirming product | Customer Complaints
Listed skills include C++, Microsoft Office, C, Matlab, and 16 others.