مهندس علیرضا بابایی

Alireza Babaei – Professional Resume 

Personal Information
Email: babaei_1648@yahoo.com

Academic Background

M.Sc. in Biomedical Engineering – Biomaterials
University of Tehran, Iran (2015–2018)
Thesis: Preparation and characterization of antibacterial chitosan–nano bioactive glass films for periodontal regeneration.

B.Sc. in Metallurgy Engineering
Islamic Azad University, Najaf Abad, Isfahan (2008–2011)
Thesis: Manufacturing of AlMgO₃ using milling method for explosive applications.

Professional Certifications & Training

• ISO 13485 Lead Auditor – Interconformity / USCERT

• ISO 9001 Lead Auditor – AJA Academy / USCERT

• ISO 14001 Lead Auditor – Interconformity

• OHSAS 18001 Lead Auditor – Interconformity

• ISO 14971 (Risk Management) – DIMITTO

• IEC 60601-1 – IMEDSS

• ISO 11607, ISO 10993, ISO 11737 – Kiananozist Vista

• Medical Device CE Requirements – RSI

• MDD Introduction – RSI

• Technical Supervisor (MOH Requirements) – IMEDSS

• Cleanroom Validation – RSI

• IATF 16949:2016 – KIWA CERMET

• 5S Training – DIMITTO

Work Experience

Freelance Lead Auditor
USCERT & IGC (2018–Present)

• Conducting certification, surveillance, and initial audits for medical device manufacturers under ISO 13485:2016and ISO 9001:2015.

Auditor – SZUTEST Notified Body
2020

Technical Assistant / Auditor – Kiwa Cermet
2016–2018

Technical Supervisor – Vira Visman (Medical Gas Systems)
2015–2016

Technical Supervisor – Hava Gostarane Amin Pars (Oxygenator Production)
2011–2013

Quality Manager – Arman Felez (Metal Forming)
2010–2011

QA Assistant – Jahan Zobe (Metal Forming)
2008–2009

Key Skills

• Excellent English (Speaking, Reading, Writing)

• Medical Device Technical File preparation

• Medical device classification and regulatory requirements

• Expertise in biomaterials and medical device categories

• Strong understanding of international management systems

• Experience in supervising medical device manufacturing

Audit Experience Summary

• Extensive auditing experience with over 150+ medical device companies

• Roles performed: Lead Auditor / Auditor

• Standards: ISO 13485:2016, ISO 9001:2015, CE 93/42/EEC, MDR-related assessments

• Audit Types: Certification, Surveillance, Recertification, Initial, Extension

• Fields covered: IVD, orthopedic implants, disposable devices, sterilization equipment, active devices, respiratory devices, dental units, hospital beds, wound care, NPWT, laboratory equipment, radiology, navigation systems, and more.