Mahmoud Saleh

Cellular Phone: +2-010********

Email: adhmlr@r.postjobfree.com

Professional Experience

Smart Tech Solution – Orthopedic Implants Medical Devices – April 2016 till now.

Title: Quality Assurance Manager – Full Time

Conduct and supervise quality system activities,

Management Representative for the quality system,

Co-ordinate the implementation and follow-up the CE mark MDD 93/42/EEC requirements (including issuance of the Technical Files, conducting risk analysis and classify the products),

Prepare FDA 510K files,

Quality Management System transition from ISO 13485:2003 to ISO 13485:2016.

Conducted ISO 13485 quality audits,

Customer Technical Support and Complaints Handling,

Quality orientation training (e.g. GMP, Quality Basics, Quality System, ISO 13485 and CE-Mark Requirements, and quality improvement tools induction),

Validation activity performance; manufacturing processes, cleaning process, surface treatment processes,

Member of the Product Development Committee,

Act as Surface Finishing and Treatment section head for 1 year. MA Medical – Medical Devices – Jan 2014 to March 2016 Title: Quality Manager – Full Time

Conduct and supervise quality system activities,

Management Representative for the quality system,

Co-ordinate the implementation and follow-up the CE mark MDD 93/42/EEC requirements (including issuance of the Technical Files, conducting risk analysis and classify the products),

Issue and Approve quality control inspection instructions and test methods,

Quality Control final approvals,

Microbiological, Physical and Chemical Laboratory supervision,

Conducted ISO 13485 quality audits,

Customer Technical Support and Complaints Handling,

Quality orientation training (e.g. GMP, Quality Basics, Quality System, ISO 13485 and CE-Mark Requirements, and quality improvement tools induction),

Validation activity performance; sterilization process and clean room,

Project Manager for Clean Rooms & EtO Sterilizer,

Non-Conformance analysis and quality cost evaluation. Afri Medical – Medical Devices – Jan 2013 to Dec 2013 Title: Quality Control Supervisor – Full Time

Mahmoud Saleh

Cellular Phone: +2-010********

Email: adhmlr@r.postjobfree.com

Supervise all quality control activities for hemodialysis section,

Carry out all product testing on time and in full.

Update technical files of hemodialysis products (dialyzer, blood line and fistula needle) including updating clinical evaluation report, risk management report and review the compliance to updated harmonized and international standards,

Provide weekly and monthly Q.C performance reports to quality manager,

Act as Q.A section head for 5 months,

Update risk management reports from being in compliance with ISO 14971: 2007 to EN ISO 14971:2012,

Participate in internal audits program,

Participate in establishment and updating of Procedures and SOPs. Euromed for Medical Industries – Medical Devices – Oct 2010 to Dec 2012 Title: Quality Supervisor – Full Time

Implementation of Quality Management System in compliance with ISO 13485:2003 and MDD 93/42/EEC,

Participate in ISO 13485 internal audits,

Report audit findings to the relevant persons and follow up corrective and preventive actions execution,

Participate in establishment and updating of and SOPs,

Carry out all product measurement and testing,

Provide weekly and monthly reports to managers on performance,

Deal with Egyptian regulatory body for registration of company products,

Submit and follow up of files and documents,

Registration of company products in Brazil, Tunisia, Saudi Arabia, Ecuador and Pakistan,

Update products technical files for CE surveillance. Maramco – Medical Devices – April 2017 to July 2018 Title: Quality Consultant – Part time

Prepare technical documentations for CE submission for wound dressing, surgical gloves and Foley urinary catheters,

Establish a QMS in compliance with ISO 13485:2016 and follow up implementation,

Conduct training to company employees on ISO 13485:2016 and European regulations of Medical Devices.

MDM Company – Medical Devices – Jan 2016 to July 2016 Title: Quality Consultant – Part time

Prepare technical documentations for CE submission for medical device disinfectants, infusion set, blood line and blood transfusion set. Mahmoud Saleh

Cellular Phone: +2-010********

Email: adhmlr@r.postjobfree.com

Establish a QMS in compliance with ISO 13485:2003 and follow up implementation,

Conduct training to company employees on ISO 13485:2003 and European directive of Medical Devices.

SAS Company – Medical Device – March 2015 to Sep 2015 Title: Quality Consultant – Part time

Prepare technical documentations for CE submission for syringes,

Establish a QMS in compliance with ISO 13485:2003 and follow up implementation,

Conduct training to company employees on ISO 13485:2003 and European directive of Medical Devices.

Education

Bachelor ‘s degree in Bio chemistry, faculty of Science, Ain Shams University

(2006:2010).

Training

EN ISO 13485:2016 training course from Ietqan Consultancy.

MDR Training course from Ietqan Consultancy.

ISO 9001 – Quality Management Systems Auditor / Lead auditor Training Course from SGS, Egypt.

Awareness of EU Medical Device Directive (MDD 93/42/EEC) by TERUMO EUROPE.

Training on Clinical Evaluation of medical device by TERUMO EUROPE.

Training on Application of Risk Management to medical device by TERUMO EUROPE.

Training on Process Validation by TERUMO EUROPE.

Training on Design and Development of Medical Devices by TERUMO EUROPE. Personal and Contact Information

Name: Mahmoud Ahmed Saleh

Date of Birth: June 8, 1989

Nationality: Egyptian

Address: 40 El Horia Institute, Gesr EL Suez Road, Cairo, Egypt.

Cellular Phone No.: +2-010********

Email Address: adhmlr@r.postjobfree.com

Contact this candidate