Fatma Ali Email & Phone Number
Quality and Regulatory Auditing - Medical Devices @ Fma Consulting LLC
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Fatma Ali Location
- Houston, TX, US
Fatma Ali Work
- Quality and Regulatory Auditing - Medical Devices @ (April 2012 - Present)
- President-Owner @ (September 2012 - Present)
- Principal- MDR-QMS and ISO 13485 auditor @ DNV Product Assurance AS (April 2025 - July 2026)
- Lead Auditor ISO 9001 @ DNV Product Assurance AS (February 2016 - July 2026)
- Sr. Lead Auditor-13485, MDSAP, MDR @ DNV Product Assurance AS (April 2017 - April 2025)
- Lead Auditor ISO 13485:2016-MDD @ DNV Product Assurance AS (February 2016 - April 2017)
- Director of Quality Systems @ (January 2013 - April 2015)
- Director of Quality and Regulatory Affairs @ (July 2008 - August 2012)
- Director of Quality and Regulatory Affairs @ (July 2007 - July 2008)
- Quality and Regulatory Affairs Manager and Senior Quality Engineer @ (June 2005 - May 2007)
- Senior Quality Assurance Engineer @ (June 2004 - June 2005)
- Quality Manager @ (August 2000 - June 2004)
- Quality Assurance Manager @ POPI International (September 1997 - July 2000)
- QC Inspector @ (September 1995 - August 1997)
- Director of Electromechanical Projects @ Egyptian ministry of Housing, Utilities & Urban Communities (January 1983 - August 1995)
Fatma Ali Education
- Delaware State University
Graduate Student (Physics)
1995-1996 - Assiut University
BS (Electrical Engineering)
1978-1982 - College of Engineering, Assiut University
Bachelor's degree (Electrical and Electronics Engineering)
1977-1982
Fatma Ali Skills
- 21 CFR Part 11
- ASQ-Certified Quality Auditor
- Biotechnology
- CAPA
- CE marking
- Change Control
- Compliance
- Continuous Improvement
- Design Control
- Document Management
- Engineering
- FDA
- FMEA
- GMP
- ISO
- ISO 13485
- ISO 14971
- ISO 9001 Quality Management system
- Iso 9000
- Lean Manufacturing
- Medical Device-Clinical Evaluation
- Medical Devices
- Problem Solving
- Process Development
- Process Engineering
- Process Improvement
- Process Simulation
- Process Validation
- Product Development
- QSR
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Management
- Quality System
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Risk Management
- Root Cause Analysis
- SPC
- Six Sigma
- Software Documentation
- Sop
- Strategic Planning
- Supplier Quality
- Testing
- V&V
- Validation
- cGMP practices
- Asq Certified Quality Auditor
- Medical Device Clinical Evaluation
- Regulatory
- Records
- Audits
Fatma Ali Summary
- Fatma Ali, based in Houston, TX, US, is currently a Quality and Regulatory Auditing - Medical Devices at FMA Consulting, LLC. Fatma Ali brings experience from previous roles at FMA Consulting, LLC and DNV Product Assurance AS. Fatma Ali holds a 1995 - 1996 Graduate Student in Physics @ Delaware State University. With a robust skill set that includes 21 CFR Part 11, ASQ-Certified Quality Auditor, Biotechnology, CAPA, CE marking and more. Fatma Ali has 2 emails and 3 mobile phone numbers on RocketReach.
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