Michael Neaves                                                                                                                 

Sr. Quality Engineer

Mike has 19 years experience in the medical device industry in the areas of engineering, manufacturing and quality assurance. A former Quality Systems Director for a Fortune 500 company, Mike has specific experience 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. Other experiences include device design, manufacturing engineering, re-engineering and validation. 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.

EXPERIENCE

• 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.

POSITIONS HELD

• Sr. Quality Engineer                                                                                      BioTeknica
• 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                                                                      

EDUCATION

• MBA                                                                                                               University of Miami
• BS Electrical Engineering                                                                              Florida International University

CONTINUING EDUCATION

• ISO 9001 Lead Assessor
• Computer System Validation
• FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• Six Sigma