Fatima Benali
42 Rue de la Liberté
Algiers, Algeria 16000
+213 21 547 8923 | fatima.benali@email.com
https://www.linkedin.com/in/fatimabenali

PROFESSIONAL SUMMARY

Results-driven Quality and Compliance Manager with over 15 years of progressive experience in quality management systems, regulatory compliance, and operational excellence across the Asia-Pacific region. Proven expertise in implementing and maintaining ISO standards, GMP compliance, and lean manufacturing principles. Demonstrated success in leading cross-functional teams, managing supplier relationships, and driving continuous improvement initiatives that reduce non-conformances by up to 40% while ensuring full regulatory adherence.

PROFESSIONAL EXPERIENCE

Quality and Compliance Manager, Asia
Medtech Solutions Group | Singapore | January 2020 – Present

Lead quality assurance and regulatory compliance operations across manufacturing facilities in five Asian countries, ensuring adherence to ISO 9001, ISO 13485, ISO 14001, and GMP standards. Manage a team of 12 quality professionals and oversee annual compliance budgets exceeding $2.5M.

• Spearheaded implementation of ISO 13485:2016 certification across three manufacturing sites, achieving zero major non-conformances during external audits
• Reduced customer complaints by 35% through systematic root cause analysis using Six Sigma DMAIC methodology and Minitab statistical tools
• Established supplier quality management program for 45+ distributors and suppliers, implementing quarterly audits that improved supplier performance ratings by 28%
• Led successful regulatory inspections by health authorities in Japan, Singapore, and Australia with zero critical findings
• Implemented TrackWise quality management system across regional operations, improving CAPA closure rates from 65% to 92%
• Developed and delivered GMP training programs to over 200 manufacturing personnel, achieving 98% compliance in annual competency assessments
• Collaborated with R&D and Operations teams to integrate quality requirements into new product launches, reducing time-to-market by 20%

Senior Quality Assurance Manager
Pacific Manufacturing Industries | Bangkok, Thailand | March 2016 – December 2019

Managed quality assurance operations for medical device manufacturing facility, overseeing quality control, document management, and compliance activities for production volumes exceeding 5 million units annually.

• Directed transition from paper-based to electronic quality management system using Documentum, reducing document retrieval time by 75%
• Achieved and maintained ISO 9001:2015 and ISO 14001:2015 certifications through comprehensive internal audit programs
• Implemented lean manufacturing principles that reduced waste by 22% and improved first-pass yield from 89% to 96%
• Led cross-functional Six Sigma Green Belt projects resulting in $850K annual cost savings
• Managed SAP quality module implementation, streamlining inspection processes and improving data accuracy by 40%
• Established key performance indicators dashboard for executive leadership, providing real-time visibility into quality metrics

Quality Engineer
Precision Components Ltd | Kuala Lumpur, Malaysia | June 2012 – February 2016

Executed quality engineering activities for stamping and assembly operations, including process validation, statistical process control, and supplier quality management.

• Conducted process capability studies using Minitab, improving Cpk values from 1.2 to 1.8 for critical stamping operations
• Performed root cause analysis and implemented corrective actions that reduced scrap rates by 30%
• Collaborated with suppliers to resolve quality issues, conducting on-site audits and implementing improvement plans
• Developed and maintained quality documentation including control plans, FMEAs, and work instructions
• Supported new product introduction activities, ensuring design for manufacturability and quality requirements

Quality Technician
Industrial Manufacturing Corp | Ho Chi Minh City, Vietnam | August 2009 – May 2012

Performed incoming, in-process, and final inspections for manufacturing operations, ensuring product conformance to specifications and customer requirements.

• Conducted dimensional inspections and functional testing using precision measurement equipment
• Maintained calibration records and managed measurement systems analysis programs
• Documented non-conformances and participated in corrective action investigations
• Supported internal and external quality audits with documentation and evidence preparation

EDUCATION

Master of Science in Quality Management
University of Algiers | Algiers, Algeria | 2014

Bachelor of Science in Industrial Engineering
Technical University of Oran | Oran, Algeria | 2009

CERTIFICATIONS & TRAINING

• Certified Six Sigma Black Belt (ASQ)
• Certified Quality Manager (ASQ)
• Lead Auditor – ISO 9001:2015
• Lead Auditor – ISO 13485:2016
• Lean Manufacturing Certification
• GMP for Medical Devices

CORE COMPETENCIES

Quality Management Systems: ISO 9001, ISO 13485, ISO 14001, GMP, FDA 21 CFR Part 820
Quality Tools & Software: Six Sigma, Lean Manufacturing, Minitab, TrackWise, SAP QM, Documentum
Technical Skills: Statistical Process Control, Root Cause Analysis, CAPA Management, Process Validation, Risk Management (FMEA, PFMEA)
Operations: Manufacturing Excellence, Supplier Management, Audit Management, Document Control, Training Development
Leadership: Cross-functional Team Leadership, Change Management, Stakeholder Engagement, Continuous Improvement

LANGUAGES

Arabic – Native
English – Fluent
Mandarin Chinese – Professional Working Proficiency
French – Professional Working Proficiency

PROFESSIONAL AFFILIATIONS

• American Society for Quality (ASQ) – Member since 2011
• Asia Quality Network – Regional Chapter Leader