Principal RA/QA Consultant Babacar Diouf

Babacar Diouf brings over two decades of expertise in Engineering, Quality Engineering, Regulatory Affairs, and Quality Management Systems to his role, including a decade as an executive focusing on regulatory affairs and quality systems in the medical device industry. He has successfully obtained market clearances across multiple regions, including the USA, Canada, EU, and more, and excels in quality management within manufacturing environments. His comprehensive experience covers the entire medical device lifecycle, emphasizing regulatory planning, risk management, and various validations, including cleanroom validation.

0Prior to his current role, Babacar worked in geochemical exploration for gold and base metals in Africa, and in various capacities at companies like Autoliv ASP, CRI Medical Devices, and 3DT Holding, LLC. Originally from Senegal and fluent in four languages, Babacar holds a Geological Engineering degree and a Master’s in Executive Leadership and Organizational Change. He is a senior member of ASQ, a member of RAPS, and holds multiple certifications, including ASQ Certified Quality Auditor and ISO13485:2016 Auditor.