Babacar Diouf
Principal Consultant
- Role
- Senior Quality Engineering Consultant at Qa Consulting, Inc
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Babacar Diouf
Quality Systems, Regulatory Affairs, and Medical Device Development ServicesWe provide assistance throughout the entire lifecycle of your medical device(s). Our Services include but not limited to: • Facility registration and devices licensing/listing (USA, Canada, EU, South Korea, ASEAN, Brazil, Australia, etc.)• Regulatory submissions (Presub, IDE, 510(k), EU Technical File, Design Dossier, etc.) • Auditing,(ISO 13485, ISO 9001, QSIT, MDSAP, etc.)• Product Development Support (Regulatory Plan, Design control activities, Risk Management per EN ISO 14971, Biocompatibility testing determination and Biocompatibility Risk Assessment, Sterilization validation (EO, Gamma, E-beam, etc.), Process validation, Packaging Validation, Labeling, etc.• Facility validation including cleanroom validation• Facility transfers• Supplier Qualification• Develop, Implement, and Maintain an effective quality management system• Training on Quality Management Systems, Design Controls, Risk Management, etc.• Remediation
Experience
Senior Quality Engineering Consultant
Jan 2019 — Present · US
Education
University Cheikh Anta Diop Dakar, Senegal, West Africa
Engineer's degree, Geological and Earth Sciences/Geosciences
1991 — 1996
Northern Kentucky University
Master of Science (M.S.), Executive Leadership and Organizational Change
2010 — 2012
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