Engin Bitgen's Linkedin Analytics

Experienced Quality Consultant with a demonstrated history of working in the medical device industry and Pharmacie. Professional skilled in Quality Management Systems according to ISO 13485 and 21 CFR 820 (FDA). Special focus on CAPAs and NCRs, including remediation, preparation and execution of MDSAP and MDR audits. Performing of investigations and Root Cause Analysis on Operations related issues.