Quality Assurance and Regulations Affairs Director @ Ivory Graft Ltd.
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Denis Cengich Location
Israel
Denis Cengich Work
2025 -
now Quality Assurance and Regulations Affairs Director @
2020 -
2024 Quality and Regulatory Affairs Director @
2017 -
2020 Director of Quality Assurance and Compliance @
2015 -
2017 Director of QA and RA @
2013 -
2015 Director QA and RA @
2012 -
2013 Quality Assurance Manager @
2007 -
2012 QA Manager @
1998 -
2006 ISO and Quality Coordinator @
Denis Cengich Education
ALD College 2008
-
2008
Tel Aviv University
non-graduated
1994
-
1996
University Of Sarajevo, Bosnia and Herzegovina (former Yugoslavia)
Bachelor of Arts (B.A.)
1989
-
1993
Denis Cengich Skills
FDA
Design Control
Medical Devices
510 K
ISO 13485
Regulatory Affairs
Quality Systems
Quality Assurance
Orthopedics
Quality Management
EU
Medical Device Product Development
CAPA
Production
Biocompatibility
Regulatory Submissions
ISO 14971
Quality System
V&V
Orthopedic
European Union
Quality Auditing
21 CFR Part 11
CE marking
Software Quality Assurance
R&D
ISO
Manufacturing
Quality Control
SPC
Biomedical Engineering
Testing
Biotechnology
21 CFR
GMP
Medical Device Directive
Continuous Improvement
IEC 60601
FDA GMP
Quality Procedures
Quality System Compliance
Engineering Change Control
Iso 9000
Sop
cGMP practices
Supplier Quality
Change Control
Sterilization
Regulatory Requirements
MRB
Denis Cengich Summary
Denis Cengich, based in Israel, is currently a Quality Assurance and Regulations Affairs Director at Ivory Graft Ltd.. Denis Cengich brings experience from previous roles at HALLURA, Dune Medical Devices, HeadSense Medical Ltd. and Mavrik Dental Systems. Denis Cengich holds a 2008 - 2008 ALD College. With a robust skill set that includes FDA, Design Control, Medical Devices, 510 K, ISO 13485 and more. Denis Cengich has 2 emails and 1 mobile phone numbers on RocketReach.
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