Jonathan Vazquez
Fort Worth,TX
Summary
Aerospace Engineer with +5 years of Experience in Quality Management Systems.
· Experience in Aerospace Industry. Fuselage Assembly Experience in Medical Device industry.
· Experience in Neurovascular and Cardiovascular devices; Vascular and Surgical antiseptic devices.
Overview
11
11
years of professional experience
Work History
Quality Systems Specialist II
Becton Dickinson
El Paso, TX
06.2021 - 05.2024
- Experience with Medical Devices and Sterile Antiseptic Solution Content.
- Support and Manage Engineering Change Control.
- Support in External Audits (BSI, FDA).
- Experience with Quality Non-Conformances, Deviations, and CAPAs.
- Investigated root cause of quality issues using problem solving techniques such as 5 Whys or 8D.
- Provided guidance on regulatory requirements related to Quality Systems.
- Experience in SAP system used for Document Control.
- Prepared reports summarizing quality system performance metrics for management review.
Quality Engineer
Johnson & Johnson
Ciudad Juarez, Mexico
01.2020 - 06.2021
- Experience in Cardiovascular and Neurovascular devices (Cerenovus & Biosense Webster, Inc.).
- Collaboration in system and process improvement/optimization projects, assuring quality and compliance aspects.
- TMV, IQs, OQs, and PQs.
- Engineering Changes
- Development and control of quality standards, protocols, master documents, work instructions, SOPs, and WIs.
- Performed data analysis to identify root causes for non-conformances and CAPAs, ensuring implementation of corrective and preventive actions.
- Support in internal and external audits.
- Collaboration in the transfer projects.
- Experience with raw material production and subassembly components for cardiovascular and neurovascular devices.
- Experience with GMPs and GDPs.
Training Coordinator
Johnson & Johnson
Ciudad Juarez, Mexico
01.2019 - 01.2020
- Coordination and conducting of the training process.
- Management and maintenance of the Training System and Training Records.
- Support in the preparation of curricula of functional trainings in operations for the areas of New Products or production lines.
- Support in internal and external audits.
- Collaboration in the Investigation of Root Causes for Non-conformances and CAPAs, ensuring the implementation of corrective and preventive actions.
- Experience with GMPs and GDPs
Process Engineer
The Atlas Group
Chihuahua, Mexico
04.2016 - 09.2017
- Experience in fuselage assembly areas within the aerospace industry.
- Experience with GMPs and GDPs
- Development and control of protocols, master documents, WIs, and SOPs for manufacturing areas, ensuring effectiveness in controlled documents.
- Improvements in manufacturing areas applying Kaizen methodology.
- DFMEAs and management of measurement and calibration tools.
- Assist and Analysis of Production Metrics.
- Collaboration in the Investigation of Root Causes for Non-conformances and CAPAs, ensuring the implementation of corrective and preventive actions.
- Support in NPI Projects.
- Responsible for Tool Crib.
- Creation of Purchase Order, Quotes, Inventory Control, and Reports.
- Use and management of Pneumatic, Hydraulic, Electrical, and Mechanical tools and their maintenance.
- Set-Up for CNC, Router, and Molding Machines
Engineering Technician
American ETC
South San Francisco, CA
06.2013 - 05.2014
- Order and receiving material and perform the required identification
- Perform and document equipment repairs as per Standard Operating Procedures
- Startup, operation and shutdown equipment as per procedures
- Perform set up, adjustment, troubleshooting and repair of plant facility equipment to operate efficiently within compliance standards
- Reading, interpreting and drawing equipment diagrams in support of equipment repair & improvements
- Pneumatic, Hydraulic, Mechanical machines and tools maintenance
- Abilities with PLC's and electronic devices
- Maintain 5S status of facility maintenance areas
Education
Bachelor's Degree - Aerospace Engineer
Universidad Autonoma de Chihuahua
Chihuahua, Chihuahua, Mexico07.2015
Skills
- Quality Management Systems
- CAPAs
- Non-Conformances
- Root Cause Analysis
- Engineering Changes
- Deviations
- Document Control
- GMPs, GDPs
- Risk Management
- FMEAs
- Statistical Process Control
- Six Sigma Methodologies
- Kaizen Methodology
- 21 CFR 820, SO 9001, ISO 13485 and ISO 14971
- IQs, OQs, PQs and TMVs
- Agile MAP
- AutoCAD, Solid Works
- Minitab
- Internal & External Audits for Medical Devices (FDA, BSI, MDSAP)
Languages
English
Full Professional
Spanish
Native/ Bilingual
Timeline
Quality Systems Specialist II
Becton Dickinson
06.2021 - 05.2024
Quality Engineer
Johnson & Johnson
01.2020 - 06.2021
Training Coordinator
Johnson & Johnson
01.2019 - 01.2020
Process Engineer
The Atlas Group
04.2016 - 09.2017
Engineering Technician
American ETC
06.2013 - 05.2014
Bachelor's Degree - Aerospace Engineer
Universidad Autonoma de Chihuahua