EDGAR JOE PEREZ MORENO

I worked for different Notify Bodyes such as: BSI (2014/2022), TUVSUD(2023/2023) and NSAI(2024/Present).

Auditing different Quality Management Systems, Manufacturing Processes, Support areas, Systems used for CAPA, Complaints Handling, Document Control, MRP systems, Training areas, Validation, Risk Management, Internal Audits, Design Process for different Medical Devices. According to ISO 13485, ISO 9001.

Promotion and appointment as First Mexican to receive the category as technical expert-Microbiology-Sterilization at a global level, within the organization. Total of Auditing Days in BSI: 624 days as Leader or Team Member.
Responsible for the certification in Latin America of sites dedicated to:
- Ethylene oxide sterilization
- Gamma radiation sterilization with cobalt source
- First e-beam sterilization service provider in Mexico
- Suppliers of porcine and bovine animal tissue, for use in Class III implantable medical devices, sites in Mexico (1) and Brazil (6).
Auditor for ISO 13485 / CMDR / ISO 9001 / MDD 93/42 EEC, CE MARKING PASSIVE METAL, CE MARKING STERILE.
-Knowledge and experience auditing different Quality Management Systems, Manufacturing Processes, Support areas, Systems used for CAPA, Complaints Handling, Document Control, MRP systems, Training areas, Validation, Risk Management, Internal Audits, Design Process for different Medical Devices. Around 106 assigned different Medical Customers approximately from 30 to 3,000 employees, in at least 13 different countries.
 
KPI's Compliance in carrying out 97 audit days per year. Compliance with the approval of specific training for the technical area. Responsible for on-site training for new members of the technical area 97 to 100% customer satisfaction in each audit performed Autonomy and organization, for the planning of audits in compliance with the certification cycle. Savings of up to $15,000 USD/year, derived from proper planning and stay during audits.
-Compliance in the closure of corrective actions generated in previous
-First auditor in LATAM to certify disinfection process by means of low temperature hydrogen peroxide at an industrial level audit.

01/2005 - 06/2010
PhD in Biotechnology : Biotechnology, corrosion and electrochemistry
UNIVERSIDAD AUTONOMA METROPOLITANA - MEXICO CITY
Doctoral Intern Letter
Publication of a scientific article in Science, as a result of doctoral research.
Studies with a scholarship granted by the National Council of Science and Technology.
Knowledge and management of electrochemical techniques for studies of bacterial induced corrosion; Electrochemical spectroscopy Impedance, Electrochemical voltamperometry, SDS Page, Microbial Corrosion.
Design and sterilization of oligotrophic culture media and Protein separation
 

03/2003 - 10/2005
Master in Biotechnology : Microbial corrosion, electrochemistry and biotechnology.
UNIVERSIDAD AUTONOMA METROPOLITANA - Mexico City
Balance of culture media for the development of Biofilms under metabolic stress conditions and their use in the creation of passive films on 1018 carbon steel. Evaluation of the microbial corrosion process at the Steel/Biofilm/Seawater interface, by means of electrochemical impedance spectroscopy and scanning electron microscopy.
Research topic presented orally, in three different international conferences.
Degree with honorable mention and receipt of a university merit medal.
 

10/1996 - 02/2002
Biochemical Engineering : Biotechnology, pharmaceutical, microbiological and engineering
UNIVERSIDAD AUTONOMA METROPOLITANA - Mexico City