23 years in Quality Assurance and Regulatory Affairs, focusing primarily on Medical Devices / Software. Excels at strategic planning, building high performance teams, and project management. RA/QA Expertise Includes: Strong verbal and written communications skills, including Technical Writing (submissions, operator's guides, customer complaint handling, Quality Systems Manual writing, inspection procedures) Regulatory Affairs and Quality Assurance experience since 1991 with a strong emphasis on process and procedures based on FDA GMP/Quality Systems practices. FDA and CE Marking experience, writing 510(k) submissions, technical files, interfacing with regulatory bodies. Strong attention to detail with proven analytical and problem solving skills Ability to prioritize along critical path and meet project milestones Extensive experience using and implementing Regulatory Affairs and Quality Assurance best practices Supervisory ability and experience with multiple direct reports in multiple job capacities Ability to operate independently or in team environment
Director January 2007 to CurrentFenwal Blood Technologies, Inc － Lake Zurich, IL
Increasing scopes of responsibility for regulatory approvals and compliance for Fenwal's automated blood collection and data management systems.
Managed regulatory component of manufacturing transfer from Baxter facility to contract manufacturing facility, ensuring compliance with US and Global regulatory requirements through the transition process.
Developed regulatory strategies for product development projects.
Received clearance on multiple 510(k) applications for Class II Medical Devices.
Software Quality Assurance Analyst January 2005 to January 2007VA Office of Information, Software Design and Development － Hines, IL
Blood Bank Modernization Project.
Participated in Change Management Committee, facilitating the implementation process surrounding document and code changes.
Reviewed Quality Systems and Technical Project documentation.
Implemented changes in Quality System processes to improve process efficiency and product and process quality.
Helped define processes without written procedures.
Assisted in development of testing strategies to meet FDA requirements while expediting testing to meet deadlines.
Director January 2002 to January 2005Blood Bank Computer Systems, Inc － Auburn, WA
Directed all RA/QA tasks for FDA-regulated blood bank software applications in RPG and Java, successfully releasing a development project in two years on the job that had been stalled in design and development for 7 years, in addition to multiple additional projects.
Received 3 510(k) clearances.
Directed the quality throughout the company, enhancing and streamlining design, development, documentation, and testing procedures.
Managed all validation staff, and worked with R&D to manage project deadlines and priorities.
Quality Assurance Manager January 2001 to January 2002Ubermind, Inc － Seattle, WA
Developed QA practices for full-service enterprise application development.
Managed development projects, interfacing between the development team and the client stakeholders.
Developed and maintained high-level and detailed design specifications, project plans, test plans and results, and implementation plans.
In addition, placed out on QA contracts performing validation projects for clients (WebObjects, Java).
Quality Assurance Manager January 1999 to January 2001GreaterGood.com － Seattle, WA
Managed the full life cycle of all web applications, e.g.
www.greatergood.com, www.thehungersite.com, www.therainforestsite.com, www.gourmetgiving.com, and all associated other applications, including database access applications, client applications interfacing with the sites, and ecommerce back-end applications (WebObjects).
Developed high-level and detailed design specifications and testing documentation.
Worked directly with marketing, program managers, and developers, testing, and graphic artists to determine feasibility and timelines.
Supervised the QA testing department.
Performed content and technical QA of marketing tools (registrant emails, configurable site content, promotions).
Functioned as backup system administrator for some unix/sybase tasks.
Instrument Product Specialist January 1998 to January 1999Awareness Technology, Inc － Palm City, FL
This position was created with the inception of Awareness's new automated chemistry/ELISA analyzer, and combined customer training and service (factory and on-site), technical support, and R&D.
Installed and trained on the device in countries such as China, Turkey, and Russia.
Both Product Specialist and QA Manager positions were performed for 10 months while a replacement QA Manager was hired.
Quality Assurance Manager January 1994 to January 1999Awareness Technology, Inc － Palm City, FL
Managed quality at this medical device manufacturer, subject to the FDA regulations for medical device Good Manufacturing Practices.
Rewrote the company's Quality System in 1997 to comply with new FDA ISO-harmonized standards.
Prepared and submitted 510(k) applications for Class I Medical Devices.
Directly supervised software validation (Embedded Z80, C++), technical writing, laboratory R&D, and final device inspection departments.
Software Validation/Quality Management January 1991 to January 1992Awareness Technology, Inc － Palm City, FL
Member of Quality Management team, substantially rewrote QA Manual 11/91, wrote all instrument operator's guides.
Software validation of medical device firmware assembly code for the Z80 processor.
Wrote in-house programs using Quick Basic and Think-C (Macintosh based).
MS : Molecular/Tumor Cell Biology, 1 1994Northwestern University Medical School － Chicago, ILMolecular/Tumor Cell Biology