Arturo Kozel

Senior Consultant

Arturo (Art) has diversified operations and software experience within the FDA regulated diagnostic industry. He is a former manager and systems engineer with a solid track record in software engineering, in-vitro diagnostics manufacturing, systems engineering & integration, network security, system design & implementation, requirements analysis, and software/process validation.

 

EXPERIENCE…
  • Led Technical Team that developed and implemented an implantable medical device tracking system compliant with all applicable regulatory requirements
  • Performed Validation for application used in Computer Aided Navigation for stereotactic surgeries.
  • Co-Led Validation team responsible for remediating an SAP ERP system.
  • Validated Medical Device Software application used for plethysmography studies and classified as a Moderate Level of Concern.
  • Developed business requirements for and Enterprise Resource Planning system.
  • Designed, Developed, Implemented, and validated a Complaint Management application.
  • Wrote and implemented Computer Systems Validation guidance documents to support new Computer Systems Validation program.
  • Performed QSIT Gap assessment for Computer Systems.
  • Installed, Configured, Validated, and Deployed the Rockwell Software Maintenance Automation Control Center application suite for PLC source code management.
  • Validated the data migration from a legacy Oracle server to a state to a current state of the art server for a LIMS application.
  • Assessed, remediated, and validated FDA observations relating to a Waters Laboratory Information Management System resulting in the diagnostics division being found substantially compliant in the subsequent FDA audit.
  • Co-Led two FDA Observation response teams whose main task was to remediate the raw material Laboratory Information Management System and the CAPA application contributing to the diagnostics division being found substantially compliant in the successful response to the FDA consent decree.
  • Managed software development projects from requirements engineering stage through implementation and testing for a molecular interaction analysis system.
  • 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.
  • Co-wrote software requirements specification for the control and acquisition application for an analytical instrument.
  • Developed application to validate quality control statistics for a database application that serviced over 10,000 laboratories around the world via a private network used to establish statistical process control reports and aided laboratories meet their FDA mandated proficiency testing requirements.
POSITIONS HELD…
  • Senior Consultant – Qualified Data Systems, Inc.
  • Software/QA Specialist – BioTeknica, Inc.
  • Partner/Project Manager – The Ashvins Group, Inc
  • Systems Engineer – Medical Analysis Systems
  • OEM Manufacturing/Applications Specialist/Staff Engineer – Dade Behring
  •  Scientist II/Team Coordinator – Baxter Diagnostics
EDUCATION…
  • Ph.D., Computer Information Systems (Currently Pursuing) – Nova Southeastern University
  • M.S., Computer Information Systems – Nova Southeastern University
  • B.S., Chemistry – University of Miami
CONTINUING EDUCATION…
  • Successfully completed all the requirements for the NSA Information System Security program as specified in National Security Telecommunication and System Security Instructions (NSTISSI) 4011 and 4013
  • Quality Systems Regulation 21 CRF Part 820 refresher training
  • ISO 13485:2003 refresher training
  • Sharepoint Deployment and Administration
  • IT Infrastructure Qualification Summit
  • Fluke Networks OptiView Network Analysis and Troubleshooting Course
  • Microsoft Certified Professional & Certified Systems Engineer
  • NT 40 administration, NT40 core technologies, NT40 Enterprise, TCP/IP, Exchange 5.0, SQL server, and Internet Information Server Microsoft course work (1998)
  • Pascal (1997), Java (2000-2002)