Summary
Work History
Education
Skills
Training
Timeline
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Haitham Mohammed Ahmed

Haitham Mohammed Ahmed

Cairo

Summary

To work in a leading company & seeking a challenging position as a Qualified team member in the field of Quality which help me in developing myself to give a hand in solving problems and improvement based on my education, work experiences, creative thinking, leadership skills whereby my academic analytical and scientific background which can help in enhance work environment continuously.

Work History

ISO 13485:2016 auditor, ISO 9001 lead Auditor & medical devices consultant

  • I have over 14 years' experience within medical devices industry (Consultation & auditing, QA , regulatory affairs and QC)
  • Experience including technical documentation according to MDD & MDR, PMS, Risk management of medical devices (ISO 14971), BERs (ISO 10993), Packaging validation (ISO 11607), Clean rooms validation (ISO 14644), Sterilization by EO (ISO 11135), Sterilization by steam (ISO 17665), Qualification of equipment and process validation, Products stability study, CAPA, lead auditor, change control, deviations

Consultant

  • As a consultant, I have worked with 5 companies in Egypt and 1 Saudi Arabia to update their ISO 13485:2016 systems and Technical files to meet the requirements of the MDD and FDA
  • I have worked on a variety of medical device products, including surgical gloves, ophthalmic surgical devices, blood sugar strips, dental screws, blood lines for hemodialysis, and sodium bicarbonate.

Quality consultant

EMI company
  • Prepare technical file and follow with for CE and FDA
  • Surgical glove Latex preparation and formation, assembly, packaging and sterilization process

Quality consultant

accurate company
  • Prepare technical file and follow with EG EDA nebulizer
  • Injection and Extruder, assembly process, packaging and sterilization process

Quality consultant

Acuotech Egypt
  • Prepare technical file and follow with notified body
  • Ophthalmic surgical knives PVA
  • Injection, assembly, packaging and sterilization process

Quality consultant

  • Prepare technical file and closed point of non-conformity of notified body
  • Ophthalmic Viscosurgical Devices Eye spears

Quality Manager

ACITA for active medical devices
  • Quality manager for system and CE regulation
  • Active pressure transducer, Injection, Extruder process Assembly, packaging and sterilization process

Quality Assurance Supervisor

EG-Fresenius
  • Quality assurance supervisor ISO 13485:2015, ISO 9001-2015, ISO 45001 and 14001:2018 for 2 factories and ISO 9001:2015 for administration departments
  • Hemodialysis solution Hemodialysis machine

Quality Assurance Manager

EG medical system for medical industries
  • Update quality management system to comply with ISO 13485:2016
  • Update quality management system to comply with ISO 9001:2015
  • Update technical file to comply with CE requirement
  • Update technical file to comply with MDR requirement
  • Performing internal audit
  • Plans for internal audit and monitoring its application
  • Points out strengths and weaknesses and conclusions of the internal quality reviews
  • Perform KPIS for quality department
  • Development of quality process
  • Training all employee on the requirement of quality and GMP
  • Update objective guide wire Sterile transfusion set bloodline, infusion, of quality team

Quality Control

Interpharm for medical devices
  • 3 years as quality control, 2 years as quality assurance
  • Blood Transfusion Injection, Extruder process Assembly, packaging and sterilization process

Production Specialist

Taiser med for surgical suture
  • Absorbable and non-absorbable suture
  • Managements of production process start from rolling, cutting, assembly and sterilization process

Quality Regulatory Affairs

Extrastep Bahrain
11.2023 - Current
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Provided guidance to team members on regulatory requirements, promoting a culture of compliance within the organization.
  • Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
  • Coordinated recall or market withdrawal activities as necessary.
  • Review NHRA requirements
  • registration product with NHRA

Education

Bachelor's Degree - Botany Special

Al-Azhar University

Diploma - Biochemistry

Suez Channel, Faculty of Science

Diploma - Microbiology

Suez Channel, Faculty of Science

Diploma - Analytical Chemistry

Suez Channel, Faculty of Science

Master's Degree - Microbial Biotechnology

Al-Sadat University

Skills

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Training

  • Leader auditor training ISO 9001:2015 Course URS
  • ISO 13485-2016 training course SGS
  • MDR training course SGS
  • ISO 45000 and 14001 course URS
  • Internal Auditor Course by Consultation Company
  • Laboratory analysis Course by Al-Azhar University
  • English Course in Harvest Academy
  • English course in Not courses center

Timeline

Quality Regulatory Affairs

Extrastep Bahrain
11.2023 - Current

ISO 13485:2016 auditor, ISO 9001 lead Auditor & medical devices consultant

Consultant

Quality consultant

EMI company

Quality consultant

accurate company

Quality consultant

Acuotech Egypt

Quality consultant

Quality Manager

ACITA for active medical devices

Quality Assurance Supervisor

EG-Fresenius

Quality Assurance Manager

EG medical system for medical industries

Quality Control

Interpharm for medical devices

Production Specialist

Taiser med for surgical suture

Bachelor's Degree - Botany Special

Al-Azhar University

Diploma - Biochemistry

Suez Channel, Faculty of Science

Diploma - Microbiology

Suez Channel, Faculty of Science

Diploma - Analytical Chemistry

Suez Channel, Faculty of Science

Master's Degree - Microbial Biotechnology

Al-Sadat University

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