Principal/Senior Software Consultant
Armin has more than 20 years of management and engineering experience in the areas of quality assurance manufacturing, technical support, statistics, validation, in-vitro diagnostics quality and regulatory compliance, and software development within the pharmaceutical and medical device industries. Armin is also a Certified Software Quality Engineer (CQE) and certified instructor of Statistical Process Control and Design of Experiments.
- Principal, BioTeknica, Inc.
- Co-Founder, Qualified Data Systems, Inc., a Software Quality and Information Technology consulting firm spin-off of BioTeknica, Inc.
- Participated as a member of the Software Quality Systems team, which interfaced with Abbott Laboratories Senior Executive team to implement improvements to the software quality engineering practices. These activities enabled Abbott’s diagnostic division to be found in substantial compliance in the successful response to FDA consent decree.
- Managed multi-million dollar software development projects for Fortune 500 companies.
- Responsible for plant-wide quality data reporting, analysis, and validation services for a leading diagnostics instrument manufacturer.
- Validated Internally Developed Software, Commercial Off-the-Shelf Software, and Modified Off-the-Shelf Software Packages for companies in the Biomedical and Pharmaceutical Industries.
- Software Validation experience in Enterprise Systems (ERP), Manufacturing Execution Systems (MES), Supervisory Control and Data Acquisition Systems (SCADA), Environmental Monitoring and Control Systems (EMS), Web-Enabled Applications, and e-Commerce applications.
- Responsible for Total Quality Management of in-process quality control inspection, test, and engineering for coronary pacemaker manufacturer.
- Developed process validation standards and training programs.
- Performed product and process validations for existing and new products.
- As QA Statistical Specialist responsible for worldwide operations support in the areas of Statistical Process Control, Design of Experiments, Taguchi Methods, Process Failure Mode and Effects Analysis, and general statistical analysis.
- Principal/Senior Quality Software Consultant – BioTeknica, Inc./Qualified Data Systems, Inc.
- Manager, National Quality Assurance and Testing Practice – KPMG
- Senior Manufacturing Engineer – Coulter Corporation
- Manufacturing Quality Systems Manager – Telectronics Pacing Systems
- Corporate Quality Assurance Statistical Specialist – Telectronics Pacing Systems
- Quality Assurance Engineer – Baxter Diagnostics, Inc.
- SPC/CFM Engineer – Baxter Diagnostics, Inc.
- M.S., Quality Management – University of Miami
- B.S., Electrical Engineering – Florida International University
- A.A., Mechanical Engineering – Miami-Dade Community College
- Certified Quality Engineer – American Society for Quality Control
- Certified Software Quality Engineer – American Society for Quality Control
- Certified Statistical Process Control Instructor – Concourse Corp.
- Certified Statistical Design of Experiments Instructor – Arizona State University