Alexei P.
Lead Project Engineer at Rqm
Based in Miami, United States
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Seniority
Manager
Department
Engineering
Location
Miami
Industry
Business Consulting and Services
Company size
337
Contact information
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a•••••••@rqmplus.com
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Background
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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