Sr. Engineering Consultant with over 8 years of experience with the FDA, Regulatory Compliance, and Quality in Medical Device, Biotech, and Pharmaceutical. Aspiring to be a leader to contribute to human welfare by application of Biomedical Engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. I'm responsible and reliable, able to work within deadlines and under pressure in stressed situations. I'm a fast learner and can adapt very easily to changing environments that is shown from the different cities I've lived in and various work environments. I'm a travel enthusiast that has visited over 45 countries and an active supporter of volunteer work. This experience gives me the opportunity to engage in diverse cultures and enhance skills in team building and problem solving.Specialties:ISO 13485/14971, 21 CFRFDA Regulatory ComplianceRemediation ConsultantProject ManagementManufacturing QualitySupplier QualityLean Manufacturing, DMAIC, Six SigmaDesign ControlDHF, DMR, DHRRisk Management, FMEAProduct QualificationProcess ValidationTest Methods, MSACorrective Action Preventative Action (CAPA)Change Management / Process ImprovementAuditsPost Market Sustainability