Avner Avrahami
Quality Systems & Medical Device Specialists at QSA | Israel
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Avner Avrahami is a seasoned expert in the realm of Medical Device Quality Systems and Regulation, currently serving as a Quality Systems & Medical Device Specialist at QSA. With a robust background in ensuring compliance with stringent industry standards, Avner plays a pivotal role in establishing and maintaining Quality Management Systems that adhere to ISO 13485:2016 and ISO 9001:2015. His extensive experience encompasses all phases of product development, from initial concept through to market approval, making him a vital asset in the medical device sector.
At QSA, Avner is actively involved in preparing and submitting Medical Device Technical Files for CE Mark and FDA approval, ensuring that products not only meet regulatory requirements but also align with best practices in quality assurance. His proficiency in quality auditing, combined with his knowledge of FDA regulations and ISO standards, allows him to navigate complex compliance landscapes effectively. Avner’s commitment to process-oriented methodologies, such as Six Sigma and Lean principles, underscores his dedication to continuous improvement and operational excellence.
Key projects under Avner’s leadership often focus on enhancing quality systems through rigorous process assessments and implementing Total Quality Management (TQM) strategies. His engineering background and expertise in Statistical Process Control (SPC) enable him to drive innovation while ensuring that quality remains at the forefront of product development. Avner’s customer-focused approach not only fosters strong relationships with stakeholders but also ensures that the end-user experience is prioritized throughout the product lifecycle. As a thought leader in the industry, Avner Avrahami continues to shape the future of medical device quality systems at QSA, paving the way for safer and more effective healthcare solutions.
Quality Systems & Medical Device Specialists at QSA in March 2009 to Present
ECM N.B. Lead Auditor at Ente Certificazione Macchine in January 2014 to Present
ECM N.B Lead Auditor at Ente Certificazione Macchine in January 2016 to Present
Director of Quality Assurance & Regulatory Affairs at Neteera in June 2020 to October 2023
Director of Quality Assurance & Regulatory Affairs at Integrity Applications (IGAP) in May 2020 to October 2023
QA /RA Specialist at Toplens in March 2009 to October 2023
QA/RA consultent at Data2Life in October 2017 to June 2020
Lead Auditor at IQC in March 2015 to June 2020
QA / RA Specialist at Pure Medical in January 2010 to January 2017
Auditor at IQC in January 2015 to January 2016
QA/RA Specialist at LifeWatch in March 2015 to August 2015
QA Specialist at Alpha-Med in January 2015 to January 2015
QA / RA Manager at Integrity Applications Ltd. in April 2012 to February 2014
Quality & Regulation Director at Aspect Imaging in July 2009 to March 2012
Kodak IL Quality & Environment Manager at Eastman Kodak in October 2002 to March 2009
QUALITY ADVISER at ASD in January 2001 to September 2002
Quality manager at Israel Defense Forces in January 1997 to January 2000
Purchasing Manager at Israel Defense Forces in January 1995 to January 1998
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Process Improvement
Quality Assurance
Quality Systems
Medical Devices
ISO
Quality Management
FDA
Six Sigma
Lean Manufacturing
Change Management
Compliance
Microsoft Office
Auditing
Continuous Improvement
CAPA
ISO 13485
Quality System
Procedures Documentation
Iso 9000
Quality Auditing
Supplier Quality
Root Cause Analysis
Validation
GMP
ISO 14971
Software Quality Assurance
Quality Control
Project Management
Kaizen
5S
ISO 14001
CMMI
21 CFR Part 11
Regulatory Affairs
Industrial Engineering
Engineering
Manufacturing
V&V
Testing
SPC
CE marking
Design of Experiments
FMEA
Design Control
Cross-functional Team Leadership
21 CFR
Process Simulation
R&D
TQM
Design for Manufacturing
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Discover more about QSAWhat is Avner Avrahami email address?
Email Avner Avrahami at [email protected]. This email is the most updated Avner Avrahami email found in 2026.
How to contact Avner Avrahami?
To contact Avner Avrahami send an email to [email protected]. (updated on November 05, 2024)
What company does Avner Avrahami work for?
Avner Avrahami works for QSA
What is Avner Avrahami's role at QSA?
Avner Avrahami is Quality Systems & Medical Device Specialists
What is Avner Avrahami's Phone Number?
Avner Avrahami's phone (**) *** *** 347
Avner Avrahami Email Addresses
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