SUMMARY

• Over fifteen years’ experience rooted in design/development, Regulatory/QC and Process Management of FDA and HIPPA compliant medical devices and systems.
• Experience includes senior management of healthcare systems automation and digitization processes including patient charting and records, clinical workflow, revenue cycle management, and diagnostic imaging services.
• I also have over 10 years’ experience in producing software and systems under tight design control and Software Development Lifecycles, (SDLC). Ten plus years’ experience with business process design, implementation of process automation solutions, development of tool work instructions and training of IT staff in the use of process, tools and compliance.
• While I have a deep understanding of technology and can hold my own in any depth of technical discussion, I also possess over 15 years’ experience of translating business, system and technology requirements to all levels of an organization including c - level management and customers.

PROFESSIONAL EXPERIENCE

Confidential,Kennesaw,GA

Solutions Consultant

Responsibilities:

• Confidential is a global leader in Master Data Management (MDM) solutions. Over the last 30 years, Stibo has helped teams in the manufacturing, distribution, retail, travel & hospitality, automotive, CPG and grocery industries manage master data on a global scale. Using Confidential ' STEP technology, customers can leverage their product information assets and handle the complex product-oriented workflows needed to reconcile product and cross-channel consistencies in order to meet their omni-channel needs.
• Design, develop and execute complex MDM solutions for business partners primarily within the Retail/Catalog industry. Inbound and outbound data integration.
• Global Data modeling to support multiple upstream and downstream applications.
• Develop business process design and automation utilizing business rules, portals and workflows.
• Attribute creation and transformation.

Confidential,Alpharetta,GA

SR Business Analyst

Responsibilities:

• Conduct JAD Sessions
• Create Revise and Approve Functional Requirement Documents
• Create Revise and Approve Requirements Traceability documents (RTD)
• Coordinate with Technical Architects, Product Mangers and Quality Assurance staff to ensure deadlines are met and quality is achieved.

Confidential,Atlanta, GA

Sr. Quality Analyst

• Preparation of Test Sets for verification and validation of PICASSO system
• Coordination of testing effort with Business Analysts and end-users
• Coordination of off-shore testing resources (automated and manual), to provide just-in-time verification of new software features prior to delivery

Confidential,Atlanta,GA

Sr. QC Analyst / Metrics Design & Delivery

• Oversight and improvement of all Software Development Lifecycle processes on the Cigna Account
• Preparation of Quality Center Defect data for Sr. executive meetings, includes creation of Excel Macros
• Administration and running of Change Control process and weekly CCB meetings, preparation of CCB items, compilation of estimates and coordination of work with Cigna clients.

Confidential,Atlanta,GA

Quality Assurance / Metrics Reporting

• Facilitates the identification and mitigation of risk and promotes quality improvement throughout the entire Software Development Lifecycle, (SDLC), for projects within a given portfolio of Banking / Mortgage / Investment / Wealth Management applications.
• R esponsible for monthly EIS, (Enterprise Infrastructure Systems) BLPR, (Business Line Performance Review) reporting to senior bank management and FDIC.
• Served as Sr. BI BA Lead at SunTrust to Implement Cognos 8.3 BI, Data Warehouse and Reporting solution. Handled all relationships between data owners and consumers, handled all requirement gathering and implementation of requirements into functional results. Performed Data Source mapping and normalization, created ETL scripts and Data Scrubbing scripts and creation of detailed SQL scripting to extract custom data as requested by clients for Wealth/Fund management operations

Confidential,Atlanta,GA

Senior Quality & Process Manager

• Built competencies (Design Planning, Requirements Management, UX/UI Design, Design Review, Issue Management, Software Configuration Management, Software Verification and Validation, and Change Management) within Kodak Dental Systems for the purpose of delivering practice management and digital x-ray acquisition, processing and presentation software resulting in 10% increased productivity, higher quality products, faster development turnaround, and compliance with Food and Drug Association (FDA) Quality System Regulation (QSR)
• Directed all aspects of software quality and compliance from initial 510K submissions through issue identification, risk assessment, root cause analysis and resolution which culminated in 100% compliance with the FDA with a rare compliment from FDA inspector on market improvement since the last inspection
• Developed, trained and maintained business process related work instructions, quality record formats, and lifecycle development tools which were established as standard operating procedures for the company
• Created and sustained a metrics collection, analysis, and reporting process covering a wide range of pre- and post-market quality parameters which resulted in providing insights regarding current to baseline performance for senior management
• Customized off-the-shelf software products (Borland Caliber-RM, Borland StarTeam, HP-Mercury Quality Center (formerly known as Test Director), and HP-Mercury Quick Test Pro, (QTP) to support Kodak’s SDLC processes which resulted in increased process performance, establishment of baseline requirements, enhanced requirement traceability, and strengthened FDA QSR compliance within six (6) months