Profile Details

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Hire Khalaf A.

Saudi Arabia

USD 40 /hr

QA Director & Regulatory Expert | GMP & ISO | Chemical Analysis & Process Optimization for Medical Devices |

Profile Summary

With a Bachelor of Science in Chemistry from King Saud University and a proven tenure as a Quality Director at Advance Medical Company, I possess a comprehensive blend of hands-on experience and theoretical knowledge in both quality assurance and chemical processes. My role has empowered me to masterfully oversee medical device manufacturing operations, emphasizing productivity, efficiency, and compliance with stringent regulatory standards. My expertise in quality management is deeply rooted in a scientific understanding of chemistry and its application to ensure the integrity and safety of medical devices. This scientific perspective is crucial in my approach to developing and implementing robust quality systems, facilitating a bridge between intricate chemical properties and practical quality assurance practices. My accomplishments include leading pivotal projects from concept to commercialization, all while adhering to regulatory compliances such as FDA and SFDA standards. I have a knack for devising manufacturing standards, implementing advanced testing methods, and maintaining a high level of quality across multiple operational areas including laboratory, manufacturing, and distribution processes. Beyond operational excellence, my scholarly pursuits in the realm of chemistry have informed my involvement in research and development initiatives, contributing to the scientific community's understanding of quality in medical devices. My rigorous analytical testing, coupled with a strong foundation in chemical principles, underscores my ability to address complex quality challenges. In conjunction with my academic background, I hold Lean Six Sigma Green and Black Belt certifications, enhancing my capacity for strategic quality planning and continuous improvement. My dedication to integrating deep chemical insights into quality assurance roles positions me uniquely to drive innovation and uphold the highest standards of product excellence in the medical device sector.

Subject Matter Expertise

• ☆ Materials Science & Engineering
• ☆ Natural Product Chemistry
• ☆ Biopolymers
• ☆ Polymer Chemistry
• ☆ Analytical Chemistry
• ☆ Liquid Chromatography/HPLC
• ☆ Gas Chromatography
• ☆ Biomaterials
• ☆ Bioplastics
• ☆ Industrial Engineering
• ☆ Manufacturing
• ☆ Lean Manufacturing
• ☆ Industrial Management
• ☆ Excel
• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Design
• ☆ Quality Assurance & Quality Control (QA/QC)

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Translation

Research Fact Checking, Gap Analysis, Scientific and Technical Research, Secondary Data Collection

Consulting Go-to-Market Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping, Device Fabrication

Work Experience

Senior Quality Manager

Advance Medical

February 2020 - Present

Education

BA, Chemistry

King Saud bin Abdulaziz University for Health Sciences - Saudi Arabia

October 2016 - December 2019

Certifications

• Six Sigma Black Belt

  International Association of Six Sigma Certification

  October 2022 - Present