Summary
Overview
Work History
Education
Skills
LANGUAGES
Timeline
Generic

Jorge Gustavo Vazquez Duran

Tijuana, Baja California,BCN

Summary

Engineer with solid experience in the medical and electronics industries, focused on documentation, technical support, and validation processes. Highly organized and proactive, with strong communication skills and the ability to work effectively in cross-functional teams. Well-versed in regulatory compliance and standards, including FDA QSR and ISO 13485. Proficient in validation protocols and project management methodologies.

Overview

8
8
years of professional experience

Work History

VALIDATION ENGINEER

Medimexico
09.2023 - Current
  • Introduction of new Processes and equipment.
  • Development and maintenance of system architecture documentation (SRS, TP, TR, V&V).
  • Elaboration of risk management activities based on applicable procedures (DFMEA/PFMEA, fault trees, others).
  • Sample size calculation for V&V.
  • Validation documentation (IQ, OQ, PQ, CSV).
  • Work instruction, test method and drawing creation.
  • Quality systems (MVP, CPLN).
  • Documentation Changes (CR, DCO, MCO, ECO)
  • Creation of Temporary Deviation for V&V.
  • CAPA knowledge and Collaboration.
  • Presented findings from validation activities to stakeholders during project reviews, providing valuable insights into product quality and readiness for launch.
  • Develop timeline and track of projects (Smartsheet, GANT).
  • RCA with different methodologies (A3, Ishikawa, 5W)
  • GRR and engineering study
  • Established a robust documentation system, ensuring accurate record-keeping for all validation activities and supporting regulatory compliance efforts.

TEST ENGINEER

Jabil Healthcare
02.2022 - 09.2023
  • Design, development, maintenance and documentation of test procedures (hardware and software) to improve current production processes.
  • Definition and development of qualifications to test equipment (IQ, OQ, PQ, TMV, CSV, etc.).
  • Follow-up to Corrective and Preventive Actions (CAPA) that were assigned as responsible.
  • Transfer and introduction of new products for use in production (NPI).
  • Close pre-payroll (checks, overtime, vacations, permits, etc.) personnel under charge.
  • Supervise Test Technicians and define priorities of activities required by the work area.
  • Participate in TIC, MIC, QIC meetings providing information required by the work cell.
  • Create 4Q and track work cell metrics (Yield, Downtime, PRT, etc.).

FIELD SERVICE ENGINEER

Philips México Commercial
11.2017 - 12.2021
  • Engineering level training for the biomedical and maintenance department of the hospital.
  • Advance knowledge in operation of medical systems (US, CT, MR, MN, DXR, IXR).
  • Planned Maintenance, Corrective Maintenance, Installation and Upgrade (Software and Hardware) of medical systems.
  • Troubleshoot issues, configure operating systems, and use remote desktop connections for immediate assistance.

MANUFACTURING ENGINEER INTERN

Jabil Healthcare
04.2017 - 11.2017
  • Support in the CAPA's process: Risk analysis, CAPA opening, management plan, risk control and CAPA closure.
  • Support in the installation qualification (IQ), protocol qualification (PQ) and its respective documentation.
  • Perform and compile tests required by the manufacturing engineer or designer.
  • Implementation of engineering changes through change requisitions (CR).

Education

Bachelor of Electronic -

Instituto Nacional de Mexico

Skills

  • Minitab
  • Problem Solving
  • Equipment qualification
  • Effective communication
  • Testing protocols
  • CAPA management

LANGUAGES

English - Fluent spoken and written
Spanish - Native

Timeline

VALIDATION ENGINEER

Medimexico
09.2023 - Current

TEST ENGINEER

Jabil Healthcare
02.2022 - 09.2023

FIELD SERVICE ENGINEER

Philips México Commercial
11.2017 - 12.2021

MANUFACTURING ENGINEER INTERN

Jabil Healthcare
04.2017 - 11.2017

Bachelor of Electronic -

Instituto Nacional de Mexico

Similar Profiles

CREATE PROFILE
Jorge Gustavo Vazquez Duran