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
Ciudad Juarez, Chihuahua, México
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
Ciudad Juarez, Chihuahua, México
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, Chihuahua12.2023
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