GANI GAFAROU

Relevant and hands-on experience as Biomedical Engineer and Biomedical technology in the healthcare industry. Successful in providing biomedical equipment and device installation, maintenance and repairs. Accomplished in carefully inspecting and calibrating equipment during the installation process. Talented in providing safe and functional equipment through safety tests and regular preventive maintenance.

• A proficiency certificate in biomedical equipment technology 1, https://www.myccp.online/, Graduated: May 21 Six sigma white belt certificate, https://www.sixsigmacouncil.org/the-council-for-six-sigma-certification/
• GMP Training Certificate https://www.onlinegmptraining.com/gmp-training/store/ , Completed: May 22
• Acquired an understanding and documentation of the current GMP regulation for manufacturing
• Knowledge in the SOP and CAPA for managing deviation and non-conformances with planning
• Validation Engineering Training, BCVS Group, INC, Completed: November 2022
• Good understanding of the process validation for medical devices and computer systems
• Knowledge of the FDA regulation and recognized standards (21 CFR part 11, 21CFR 820
• 75, & ISO 13485)
• Gain knowledge of all validation documentation types (the assessments documentation, validation plan, IQ, OQ, and PQ documentation, reequipment traceability matrix, and validation summary report)
• VOLUNTEER & INTERSHIP EXPERIENCE
• Biomedical Equipment Technology 1, Bryn Mawr Hospital, Bryn Mawr PA Apr 17 – Nov 20
• Learned to test, calibrate, and analyze instruments
• Aided senior-level BIOMETS in Preforming corrective medical maintenance of several medical equipment.

A proficiency certificate in biomedical equipment

Six sigma white belt certificate,

GMP Training Certificate

· Acquired an understanding and documentation of the current GMP regulation for manufacturing.

· Knowledge in the SOP and CAPA for managing deviation and non-conformances with planning.

Validation Engineering Training, BCVS Group, INC,

· Good understanding of the process validation for medical devices and computer systems.

· Knowledge of the FDA regulation and recognized standards (21 CFR part 11, 21CFR 820. 75, & ISO 13485)

· Gain knowledge of all validation documentation types (the assessments documentation, validation plan, IQ, OQ, and PQ documentation, reequipment traceability matrix, and validation summary report).

Member, National Society of Black Engineers (NSBE)      

Member, Temple Prosthetics and Orthotics