Alexei P.
Lead Project Engineer @RQM+
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WORK HISTORY
Lead Project Engineer @RQM+
Miami, FL, US
EDUCATION
DeVry University - Westminster
Bachelor of Engineering - BE, Biomedical/Medical Engineering
Florida International University
Associate of Science - AS, Electrical and Electronics Engineering
Keller Graduate School of Management of DeVry University
Master of Business Administration - MBA, Project Management
Miami Dade College
Associate of Science - AS, Biology/Biological Sciences, General
ABOUT ALEXEI P.
Experienced Engineer with a demonstrated history of working in the biotechnology and Medical Device Industry. Strong working of knowledge of design controls, ISO 14971, IEC 62304, IEC 60601, 510K submissions, USFDA Quality System Regulations for Medical Devices; EU IVD/MDD/MDR, ISO 13485 Quality Standard, QSR, and ISO requirements, Validation/Verification, and CAPA process, FMEA/FTA/Usability. Experience of the pre and post-market Quality aspects of the medical device product lifecycle. Manufacturing Transfer including plants in Latin America.
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