Team

Alex Spivak

Principal Consultant

Alex is a highly strategic Biomedical Engineer with 13 years of MedTech industry experience, specializing in solving complex R&D challenges and ensuring strict Quality Assurance and Compliance. Alex transforms product development through rigorous statistical analysis and process optimization, consistently delivering substantial quality enhancements and guaranteeing minimal Post Market Surveillance complaints. As the lead Quality Engineer for numerous global commercial product launches, he has successfully operated in diverse environments, from large corporations to small startups, and across multiple domestic and international locations, including Japan. 

Academic & Professional Qualifications:
  • B.S. Biomedical Engineering, University of Cincinnati – Cincinnati, OH 
  • Certified Quality Engineer (CQE): American Society for Quality (ASQ) 
  • People Manager Qualification (PMQ): Society for Human Resource Management 
  • Design Control Requirements and Industry Practice: Association for the Advancement of Medical Instrumentation (AAMI) 
  • Protecting Human Subject Research Participants: National Institutes of Health (NIH) 
Training, Quality Systems, & Specialties:
  • R&D Quality Engineering (BioTech / MedTech / Pharma / Combo Device) 
  • Partner/Customer/Client Relations 
  • Product Development and Commercial Launch 
  • Design Controls 
  • Risk Management and FMEAs 
  • Statistical Techniques and Process Control 
  • Measurement System Analysis and Test Method Validation 
  • Design Verification and Validation 
  • Customer Complaint Handling 
  • Corrective And Preventive Actions (CAPAs) 
  • Regulatory Authority Audits (Front Room/Back Room/SME) 
  • ISO 13485 
  • ISO 14971 
  • 21CFR820