Professional Experience

MEDIWARE INFORMATION SYSTEMS, Melville, NY                                                                                            1999 - 2000
Director Regulatory Affairs and Quality Assurance

• Directed the quality, regulatory, product validation, and product safety initiatives for a developer of blood bank, pharmacy and operating room information systems. Implemented automated software testing significantly reducing cycle time and providing a new product and service for sale to clients. ‘Harmonized’ the quality systems of three ‘merged’ product centers. Implemented QSIT, electronic data/signature and HIPAA regulations.

WYNDGATE TECHNOLOGIES DIVISION, El Dorado Hills, CA                                                                            1998 - 1999
Director Quality Assurance and Regulatory Affairs

• Directed the quality, regulatory and product safety initiatives for a developer of blood bank information systems. Re-engineered entire quality management and product safety/liability mechanisms. Coordinated ongoing 510(k) submissions and all FDA interactions. Prepared for ISO 9001 certification and 21CFR11 compliance.

MOTOROLA EMTEK HEALTHCARE DIVISION, Tempe, AZ                                                                                  1993 - 1998
Assistant Vice President Quality Assurance and Regulatory Affairs

• Directed the design and implementation of the quality, regulatory, product safety and client satisfaction initiatives for a developer of clinical information systems. Quality programs included the SEI CMM, Six Sigma quality, process mapping cycle time reduction, and Motorola Quality System Review, which has been ISO 9001 certified. Worldwide client base including in Europe, Japan and Australia. Member Motorola Corporate Product Safety Council.
   

SUNQUEST INFORMATION SYSTEMS, Tucson, AZ                                                                                              1991 - 1993
Director of Quality Assurance and Regulatory Affairs

• Directed the implementation of the quality, regulatory, and product safety initiatives for a developer of blood bank and laboratory information systems. Proactive product safety and GMP initiatives led to much less FDA compliance action than any competitors saw in newly regulated industry.

WHITE KNIGHT HEALTH CARE, Asheville, NC                                                                                                     1988 - 1991
Director quality Assurance and Regulatory Affairs

• Re-engineered entire quality management system for manufacturer of sterile disposables. Re-instituted managements commitment to quality and safety. Managed approximately twenty 510(k) submissions. Managed 45 individuals including a Maquiladora.

JOHNSON & JOHNSON STERILE DESIGN DIVISION, Clearwater, FL                                                               1981 - 1988
Vice President Quality Assurance and Regulatory Affairs   (1983 - 1988)

• Directed quality, regulatory, safety, sterilization and laboratory functions for custom sterile procedure pack manufacturer. Pioneered implementation of 1978 FDA Medical Device Amendments. In 12 inspections at three facilities, company received no FDA Form 483 during this time frame. Managed major sterilization upgrade project, approximately fifteen 510(k) submission and department of 75 individuals.

General Manager   (1981-1983)

• Overall responsibility for manufacturing division, including sterilization and distribution.
   

ZENITH ELECTRONICS, Chicago, IL and McAllen, TX                                                                                        1976— 1981

• Purchasing positions beginning as Expeditor and ending as Manager.