Vicki Little Email and Phone Number

Documentation/training coordinatorGenerate document, change control policies and proceduresMaintain the document control libraryMaintain and manage hard copy and electronic documents including master and history files, management review, and other quality recordsResponsible for overseeing Engineering Change Order process from start to releaseMaintain database systems Assist QA, Mfg and R&D with technical documentationUpdate drawing release in Solid WorksAssist with audits and inspections with the coordination preparation and compilation of documentationDocumentation Coordinator for Master Control

Test/Analyze incoming components. Documentation/Training/Administrator/Coordinator Setup/Implement Grand Avenue Software system for documentation and training.  Internal Audits (including participation in FDA/BSI) Supplier audits Calibration, CAPA and MRB Coordinator-controlled product in MRB  Create/Generate/Maintain Non-Conforming Material Reviews, Document Change Orders and Deviations

= Performed querying methods to bound potentially discrepant product = Create/Execute database queries in systems = Reconcile device populations = Assist in establishing release criteria. = Controlled potentially discrepant product using electronic and/or verbal controls = Prevent affected devices from continuing in the manufacturing or distribution processes.

= Develop a comprehensive working knowledge of statistics, process capability and control charts= Create Process Monitoring charts, analyzing and reporting on consolidated data = Perform additional testing and analysis= Participate in new preproduction startup processes= Identify job related issues/potentials for manufacturing processes and procedures =Recommend/ Implement process and procedure solutions=Research/Update/ Publish documentation for new and established procedures=Resposible for certification of assemblers on manufacturing processes and SPC programs= Lead Material Review Board on possible defected product= Participated in review of Sterilization equipment qualifications= Reviewed packaging and labeling of new design on production and first article= Frequently, actively participate and contribute in cross-departmental teams on various projects.