Fatma Ali Email & Phone Number
Principal- MDR-QMS and ISO 13485 auditor @ DNV GL Presafe AS
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Fatma Ali Location
- United States
Fatma Ali Work
- 2025 -now Principal- MDR-QMS and ISO 13485 auditor @ DNV Product Assurance AS
- 2017 -2025 Sr. Lead Auditor-13485, MDSAP, MDR @ DNV Product Assurance AS
- 2016 -2017 Lead Auditor ISO 13485:2016-MDD @ DNV Product Assurance AS
- 2016 -now Lead Auditor ISO 9001 @
- 2015 -now Quality and Regulatory Auditing - Medical Devices @
- 2013 -2015 Director of Quality Systems @
- 2012 -2013 President-Owner @ FMA Consulting, LLC
- 2008 -2012 Director of Quality and Regulatory Affairs @
- 2007 -2008 Director of Quality and Regulatory Affairs @
- 2005 -2007 Quality and Regulatory Affairs Manager and Senior Quality Engineer @
- 2004 -2005 Senior Quality Assurance Engineer @
- 2000 -2004 Quality Manager @
- 1997 -2000 Quality Assurance Manager @ POPI International
- 1995 -1997 QC Inspector @
- 1983 -1995 Director of Electromechanical Projects @ Egyptian ministry of Housing, Utilities & Urban Communities
Fatma Ali Education
- Delaware State University
Graduate Student (Senior member of ASQ Membership Chair of Section 1405 ASQ Greater Houston)
1995-1996 - Assiut University
BS (Senior Member of ASQ (Audit, BioMed, & Quality Management Divisions))
1978-1982 - College of Engineering, Assiut University
Bachelor's degree (Electrical and Electronics Engineering)
1977-1982
Fatma Ali Skills
- Medical Devices
- ISO 13485
- CAPA
- QSR
- Regulatory Affairs
- Quality Assurance
- Process Validation
- Continuous Improvement
- Regulatory Submissions
- Design Control
- Product Development
- Compliance
- Process Improvement
- Lean Manufacturing
- Biotechnology
- CE marking
- Risk Management
- Process Engineering
- Strategic Planning
- FMEA
- SPC
- Problem Solving
- Document Management
- Process Development
- cGMP practices
- Medical Device-Clinical Evaluation
- ISO 9001 Quality Management system
- ASQ-Certified Quality Auditor
- Quality System
- V&V
- Iso 9000
- Quality Management
- Process Simulation
- Validation
- ISO
- FDA
- GMP
- Six Sigma
- Engineering
- Supplier Quality
- Root Cause Analysis
- Sop
- Software Documentation
- Quality Control
- Change Control
- Regulatory Requirements
- Quality Auditing
- 21 CFR Part 11
- Testing
- ISO 14971
- Asq Certified Quality Auditor
- Medical Device Clinical Evaluation
- Regulatory
- Records
- Audits
Fatma Ali Summary
- Fatma Ali, based in United States, is currently a Principal- MDR-QMS and ISO 13485 auditor at DNV Product Assurance AS. Fatma Ali brings experience from previous roles at DNV Product Assurance AS, DNV GL and FMA Consulting, LLC. Fatma Ali holds a 1995 - 1996 Graduate Student in Senior member of ASQ Membership Chair of Section 1405 ASQ Greater Houston @ Delaware State University. With a robust skill set that includes Medical Devices, ISO 13485, CAPA, QSR, Regulatory Affairs and more. Fatma Ali has 3 emails and 3 mobile phone numbers on RocketReach.
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