Consultant and senior lecturer

• May 2022 - Present

- PMS ( Post Market Surveillance ) , PMCF ( Post Market Clinical Follow-up ) & PSUR Specialized training - Preparing PMS ( Post Market Surveillance ) file - Preparing Clinical evaluation file - MDR specialized training - ISO 13485:2016 training and consulting - PMS ( Post Market Surveillance ) , PMCF ( Post Market Clinical Follow-up ) & PSUR Specialized training - Preparing PMS ( Post Market Surveillance ) file - Preparing Clinical evaluation file - MDR specialized training - ISO 13485:2016 training and consulting

Quality Assurance Specialist

• May 2019 - Present

I am responsible for the following items: - Preparation of medical device technical file for Digital Radiography System and Analog Radiography System. - Implementing ISO 13485:2016 & ISO 9001:2015. (Establish, implement and maintain quality management system by taking risk based approach into account.) - Implementing Usability Engineering File according to IEC 62366-1 - Implementing Software Life Cycle according to IEC 62304 - Implementing and Conducting risk management according to ISO 14971:2019 - Obtaining production license of medical equipment from Ministry of Health and Medical Education IRAN. Show less

ISO 13485:2016 & ISO 9001:2015 Lead Auditor

• Jan 2019 - Feb 2020

ISO 13485:2016, ISO 9001:2015 & Technical Expert

• Dec 2017 - Jan 2019

I was responsible for the following items:- QMS site Auditor/Lead Auditor ( ISO 13485:2016, ISO 9001:2015 ) : Responsible to carrying out On-site audit at the manufacturer’s location or subcontractors production sites where applicable, for the assessment of quality management system as report into MD Directive.- Responsible for carrying out product related review (e.g. technical documentation review or examination type including aspects such as clinical evaluation, sterilization, ...)- Performing more than 40 man/days audits in the field of medical device.- Consulting to the medical equipment companies to implement the quality management system ( ISO 9001:2015, ISO 13485:2016 ) Show less

ISO 13485:2016 & ISO 9001:2015 Lead Auditor

• Mar 2015 - Nov 2017

Quality Assurance Expert and Technical Supervisor

• Jun 2015 - Dec 2017

I was responsible for following items: - Preparation of technical file of medical device. - Implementation of Medical Device Quality management system ISO 13458:2003 and ISO 9001:2015. - Product risk analyzing according to EN ISO 14971:2012 - Controlling and monitoring final products/parts. - Checking final quality controls based on quality plans and Monitoring the QC tests and Lab results. - Getting manufacturing license of medical devices like Blood Glucose Monitoring system, Blood pressure monitoring system, Surgical lights from Ministry of Health and Medical Education IRAN. Show less

Technical support expert and After sales services expert

• Aug 2014 - May 2015