Tom Sullivan

Senior Quality Consultant

Tom is a former general manager with a solid track record in quality consulting, manufacturing operations, engineering and research and development.  Tom has specific experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well FDA and third party inspections, consent decree and warning letter responses.   His expertise includes a broad background in manufacturing technologies, organizational development, and business processes.  Tom possesses a superior ability to achieve results through involvement with executive management, customers, employees and processes.

 

EXPERIENCE…
  • 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.
  • Managed a $5 million new technology development opportunity from project approval to commercial release in 18 months.  This project integrated purchased technology with division strengths in electrochemistry, metallurgy, hermetic packaging and zero defect assembly operations.  The result was a significant market advantage for a defibrillator business.
  • Managed process/equipment validation team for a leading IVD manufacturer that was under regulatory action.
  • Led process/equipment validation team for an implantables medical device manufacturer.
  • Directed a multi-disciplinary facilities and manufacturing engineering group supporting instrument and reagent production for a leading IVD manufacturer.  Annual capital projects exceeded $30million and addressed facilities expansion, production equipment procurement, and new product line manufacturing startup.
  • Instituted a comprehensive cost reduction strategy that resulted in an 8% to 10% per year reduction for five consecutive years with an overall reduction of 45% in major product lines.  These programs required design changes, method improvements, and involvement of all employees in focused teams.  Needs assessment, goal alignment, increased capability and clear performance measures were incorporated.
  • Created a highly focused and capable organization through reorganization and standardized competency training.  The division was organized into technology/market groups to replace the traditional functional hierarchy.  Decision-making was improved and individual accountability was focused on customer needs rather than functional proficiency.
  • Directed manufacturing operations at two plants with a total of 700 employees and eight major product lines.  Overall costs reduced 5% to 25% per year.
  • Restructured operations to reduce cost and headcount by 150 persons.  Rationalized and combined manufacturing, quality and engineering functions that enabled the business to operate at improved customer service levels with 17% lower cost.
  • Increased product channel capacity by 40,000 pounds per day through control system refinements without capital investment.  This increased profitability by $1.2million/yr.
  • Created an alternative control strategy to improve plant profitability by $10 million per year.  This strategy was market and profit driven rather than cost driven.
  • Initiated a project to complete a five-year capacity plan within 18 months.  The project required close co-operation between domestic and oversea sites to transfer technology and to develop Puerto Rico staff capability while the facility was expanded.
POSITIONS HELD…
  • Senior Quality Consultant – BioTeknica, Inc.
  • Quality Director – Beckman Coulter
  • General Manager – Promeon Division – Medtronic
  • Director of Operations – Promeon Division – Medtronic
  • Vice President of Operations – Baxter Diagnostics, Inc.
  • Director of Manufacturing – Baxter Diagnostics, Inc.
  • Director of Engineering – Baxter Diagnostics, Inc.
  • Senior Engineer – American Hospital Supply
  • Plant Process Engineer/Process Development Engineer – C. P. C. International
EDUCATION…
  • Executive MBA Program – University of Chicago
  • B.S., Chemical Engineering – Purdue University
CERTIFICATIONS…
  • Six Sigma – Black Belt (CSSBB)