Principal/Director, Regulatory Compliance Services/Senior Quality Engineer
As a Principal, Mike brings more than 19 years of medical device industry experience in the areas of engineering, manufacturing and quality assurance to BioTeknica. A former Quality Systems Director for a Fortune 500 company, Mike has specific expertise in design, installation, and continuous improvement of 21 CFR Part 820 and ISO 9001 compliant quality systems as well as dealing with FDA and third party inspections, Consent Decree and Warning Letter responses. Additional expertise includes device design, manufacturing engineering, re-engineering and validation and management experience in quality, manufacturing, distribution, and customer service. Mike is a certified quality auditor (ASQ) and is also registered through IRCA to conduct ISO 9001 quality system assessments.
- Principal, BioTeknica, Inc.
- Represented BioTeknica as member of the third party consultant Implementation Executive Team (IET). The IET managed all the consultant teams and interfaced with Abbott Laboratories Senior Executive team to implement new quality systems and enable Abbott’s diagnostic division to be found in substantial compliance in the successful response to FDA consent decree.
- Co-led the Production & Process Control team whose efforts contributed to significant quality system improvements and ultimately the Abbott Laboratories diagnostic division being found in substantial compliance in the successful response to FDA consent decree.
- Developed and manages Quality Systems for BioTeknica.
- Extensive quality systems experience in the Quality System Regulations for medical devices (21 CFR Sec. 820) and ISO 9001/ISO 13485 quality systems. Currently working as a senior level consultant in the medical device industry helping clients with quality system development and implementation initiatives.
- Major contributor to the quality system development efforts that moved a major medical device site from repeat FDA Warning Letters status to a follow-up inspection of no observations.
- Led the same site ISO 9001 design and installation effort that cumulated in a first time pass with no observations.
- Directly supported quality system development in the areas of Management Responsibility, Quality System, Design Control, Document & Data Control, Validation (Design, Process, Product, Software),Internal Quality Audits, and Failure Analysis.
- Experience in conducting third party audits to the ISO 9001 requirements.
- Electronics design engineer with microprocessor and microcontroller based circuits in the medical device industry.
- Participated in a corporate wide effort to establish CAD/CAM standardization of mechanical design, PCB layout design, and CAM software for prototype and production applications.
- Various manufacturing and quality management experience, areas include instrument pilot production, instrument engineering/design, document systems, labeling/printing operations, immunohematology operations, distribution, customer service, and quality assurance.
- Extensive project management experience, both in the team leader and member role.
- Principal/Director, Regulatory Compliance Services/Senior Quality Engineer – BioTeknica, Inc.
- Director, Quality Systems – Dade Behring, Inc.
- Director, Distribution & Customer Service – Baxter Healthcare, Inc.
- Manager, Immunohematology Operations – Dade Diagnostics
- Manager, Labeling and Printing Operations and Quality Assurance – Dade Diagnostics
- Manager, Document Systems – Dade Diagnostics
- Manager, Instrument Engineering & Mfg. Services – American Dade
- Production Engineer – American Dade
- Electronics Design Engineer – Innovative Electronics
- M.B.A. – University of Miami
- B.S., Electrical Engineering – Florida International University