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director resume example with 20+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Executive Summary
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
Core Qualifications
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Professional Experience
Director, 01/2007 to Current
Department Of AgricultureTucson, AZ,
  • 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, 01/2005 to 01/2007
Cgi Group Inc.Portsmouth, NH,
  • 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, 01/2002 to 01/2005
Department Of AgricultureJackson, WY,
  • 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, 01/2001 to 01/2002
PeratonFort Meade, MD,
  • Directed software QA for internal and external web-site development (HTML, JavaScript, XML), internal development tools, and contract development projects for ecommerce, banking, and telecom applications.
  • 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, 01/1999 to 01/2001
PeratonFort Gordon, GA,
  • 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, 01/1998 to 01/1999
PeratonBethesda, MD,
  • 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, 01/1994 to 01/1999
Awareness Technology, IncCity, STATE,
  • 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, 01/1991 to 01/1992
Awareness Technology, IncCity, STATE,
  • 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).
Education
MS: Molecular/Tumor Cell Biology, Expected in 1 1994 to Northwestern University Medical School - Chicago, IL
GPA:
Molecular/Tumor Cell Biology
BS: Chemistry/Biochemistry, Expected in 1 1991 to University of Notre Dame - Notre Dame, IN
GPA:
Chemistry/Biochemistry
Affiliations
Skills
application development, assembly, backup, banking, C, C++, Change Management, com, content, contracts, client, clients, data management, database, product development, documentation, ecommerce, ELISA, full life cycle, graphic, HTML, in design, ISO, Java, JavaScript, Macintosh, marketing, access, Quick Basic, enterprise, processes, project plans, Quality, Quality Management, QA, RPG, sybase, system administrator, technical support, technical writing, telecom, some unix, validation, web applications, web-site development, written, XML

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Resume Overview

School Attended

  • Northwestern University Medical School
  • University of Notre Dame

Job Titles Held:

  • Director
  • Software Quality Assurance Analyst
  • Director
  • Quality Assurance Manager
  • Quality Assurance Manager
  • Instrument Product Specialist
  • Quality Assurance Manager
  • Software Validation/Quality Management

Degrees

  • MS
  • BS

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