Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
Fernando Larios Salas

Fernando Larios Salas

Ciudad Juárez,CHH

Summary

I am a biomedical engineer, as a person I consider myself a hard worker and a dreamer who knows how to work in a team, but also enjoys to work individually, I am a punctual and responsible person and also a fast learner and proactive, I like to discover new abilities that I didn't know I could have so I can get out of my comfort zone to discover it.

Overview

2
2
years of professional experience
1
1
Certification

Work History

Document Control Specialist

ILC Dover
02.2024 - Current
  • Quality Management System Coordination.
  • CAPA's corrective actions and Verification
  • internal audits of the FSSC 22000 - ISO 9001 and ISO 13485
  • Leader Auditor in ISO 13485 Medical Devices
  • Perform document changes for 3 different business units (Alimentary, Pharma and Medical Devices)
  • Coordination of internal audits.
  • Open and Closure meetings for internal audits.
  • Customer Audits and 3rd Party Audits (Certification ISO)
  • Iron Mountain storage of DHRs (Device History Record) Process.
  • Perform and coordinate document Migration From paper system to Digital Software (Master Control)
  • Effective Communication with the Corporate team
  • Training on document changes


Quality intern

ILC Dover
04.2023 - 02.2024
  • Effective communication in English and Spanish with the organizational levels of the company.
  • Help and support with Customers complaints
  • Support on Pharma business Unit Validations IQ, OQ, PQ
  • Process Capability Studies in ISO 7 and ISO 8 clean rooms based on ISO 90001 standards.
  • Support in customer audits in the pharmaceutical business according to the ISO 9001 2015 standard.
  • Support to manufacturing processes in ISO 7 and ISO 8 clean rooms based on ISO 90001 standards, particle monitoring.
  • Development and follow-up of customer approvals on the Medical and Pharmaceutical industry.
  • Structuring of DHRs, history of the manufactured product.
  • Support and supervision Validation Tools
  • Good Documentation Practices.
  • Good manufacturing practices.

Education

Bachelor's Degree - Biomedical Engineer

Universidad Autónoma de Ciudad Juárez
Ciudad Juárez, Chihuahua
12.2023

Technician - Refrigeration and Air Conditioning

Centro de Bachillerato Tecnológico Industrial y de Servicios # 128
06.2017

Skills

  • Microsoft Office
  • AutoCAD
  • Minitab
  • Regulatory compliance
  • Team Guru
  • ERP System
  • Document review
  • Records management
  • Database maintenance
  • Internal Audits
  • Kaizen events
  • CAPA's
  • Customer Complaints
  • KPI's
  • Data accuracy
  • Auditing documents
  • Confidentiality handling

Certification

  • Competence accreditation course in Microsoft technologies for productivity, SEP, 2015-06-01
  • Lean Six Sigma White Belt, Lean Six Sigma, 2023-09-01
  • Internal Auditor ISO 9001:2015, Global Std., 2023-11-01
  • Internal Auditor FSSC 22000 V6, Global Std., 2023-11-01
  • Lab-View Certificate, UACJ, 2023-12-01
  • Applied Statistics for Process Validation in Medical Devices, Regulatory Compliance Associates, 2024-04-01
  • Global 8D's, Grupo Dextro, 2024-07-01
  • Leader Auditor ISO 13485: 2016, Global Std., 2024-08-01

Languages

Spanish
English

Timeline

Document Control Specialist

ILC Dover
02.2024 - Current

Quality intern

ILC Dover
04.2023 - 02.2024

Technician - Refrigeration and Air Conditioning

Centro de Bachillerato Tecnológico Industrial y de Servicios # 128

Bachelor's Degree - Biomedical Engineer

Universidad Autónoma de Ciudad Juárez

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