Software Quality Engineer
Javier has extensive experience with design, development, implementation, testing, deployment, and training in software and hardware platforms. He possesses a wide-ranging knowledge of developing, testing and documenting software validations as well as other validation activities. Javier has a solid track record in the management of software engineering, systems engineering and integration, network security, system design, requirements and risk analysis, and software/process validation projects.
- Responsible for the development and implementation of Computer Systems Validation guidance documents to support a new Computer Systems Validation program for a medical device diagnostics manufacturer. Implementation included development and execution of site training programs.
- Assessment, remediation and validation of quality control product testing applications for a diagnostics manufacturer.
- Responsible for designing, developing and implementing an Application Lifecycle Management solution for a medical device manufacturer. The solution integrated both their hardware and software platforms. Key features included change management, build process, test case management as well as validation.
- Led technical team on the development of a web-based product registration tracking application for a medical device manufacturer. The solution was able to facilitate management, tracking, and reporting of global registration activities from the manufacturer through distributors, hospitals, physicians and patients.
- Responsible for the design, validation, and implementation of a global compliant management system which integrated with over 50 different franchises and partners.
- Responsible for development of Test Method Validations for a manufacturing grinding processes for a medical equipment manufacturer.
- Conducted supplier qualification audits for an outsourcing initiative for a medical equipment manufacturer.
- Responsible for conducting Computer Systems QSIT Gap Assessments for Medical Device manufacturers
- Extensive SDLC documentation experience from requirements engineering stage through implementation for custom and off the shelf applications.
- Developed and implemented Computer Systems Validation.
- Responsible for managing, maintaining, upgrading, and implementing Enterprise systems including email servers, CRM database, network connectivity for both UNIX and NT servers, firewall and security policies, LAN and WAN connectivity, Virtual Private Network implementation and management, call center phone system management, image processing systems, and all IT facility maintenance issues.
- Software Quality Engineer – Qualified Data Systems, Inc.
- Software/QA Consultants – BioTeknica, Inc.
- B.A., Communications – American Intercontinental University
- Quality Systems Regulation 21 CRF Part 820 Training
- ISO 13485:2003 Training
- Project Management Professional (PMP) Program
- SharePoint Deployment and Administration
- Fluke Networks OptiView Network Analysis and Troubleshooting Course