Sarabeth Smith Email & Phone Number

North Port, Fl, Us

Florida, United States

Remote

Sarasota, Florida Area

Became an in-house expert in Volume Graphics and Space Claim in two months; then applied the full software capabilities to the CT scan analysis and reverse engineering, increasing efficiency and throughput capabilities. Identified and eliminated 80% of redundant work efforts in the mold validation process by programming FAI (First Article Inspection) Marcos into Volume Graphics, which also significantly reduced human input error.Cultivated relationships with potential customers and current clients through direct interactions at NPE trade show by successfully communicating the benefits of integrated metrology, manufacturing, and tooling capabilities.Directly interfaced with customers identifying their objectives allowing the lab to provide appropriate quotes, deliver precise reports, and ensure customer satisfaction.Established trust with technicians and operators by listening to their concerns, root-causing issues, and effecting change to improve production environment.Revised product inspection process procedure by focusing on key points to enhance employee comprehension, removing unnecessary details and upgrading document security to maintain integrity. Designed a production process cavity separation system and lead the implementation across multiple departments, eliminating quality control risk and reducing product loss by 75%.Developed, planned, and implemented the layout of the lab work-space.---Ergonomic design principles used on repetitive task to reduced injury risk---Created professional look with high functionality, space usage, and growth capabilities. ---Gathered support of colleagues and used persistence to convinced CFO to fund and back the project. Utilized lean manufacturing best practices when installing and training team on a new part storage system process and procedure that reduced manufacturing waste.

Alpharetta, Ga

Shifted work responsibilities from Global R&D team to Global Quality as part of company re-organization. Drove initiative to create global document and template repository for all controlled documents as per ISO 9001 requirements. Informed executives on status of regional-to-global processes harmonization and progress on development of project SharePoint sites. Stepped up to ensure all required team responsibilities proceeded effectively while my manager, the Director of Group R&D Quality, was on short-term disability.

Alpharetta, Ga

Integral part of team defining Global R&D Project Governance Process for transition from regional process for over 150 projects for 10+ countries. Lead project managers through transition from regional to global R&D, ensuring full understanding of new organization structure and process. Scheduled, coordinated agenda, and led Project Governance Board meetings for Americas and Asia Pacific regions, involving 75+ projects requesting approvals for various project gates and change requests. Joint coordinator of process steering committee governing, reviewing, and approving all changes to global project deliverable templates and related processes, ensuring that any alterations aligned with the business goals and regional differences. Worked directly with four business units for effective worldwide synchronization as part of larger team effort to develop a global project deliverables list by harmonizing 12 regional lists. Provided Sciforma (project management software) support for annual $100+ million Americas R&D budget planning to PMO and R&D managers. Developed global project SharePoint sites in collaboration with Australian IT team, providing senior management with online voting system for project gates and change requests to increase process efficiency and accountability. Managed cultural and time zone challenges working with 50+ associates from 10+ countries ensuring efficient progress toward business objectives.

Alpharetta, Ga

Served as resource to project managers as New Product Introduction Process expert, providing guidance, making process updates, and monitoring performance metrics. Increased efficiency of Project Gate Review meetings to the executive board from 2-3 presentations per 1-hour meeting to 6+ by improving presentation format. Streamlined project status updates in Sciforma by guiding 15 project managers through system and process updates, allowing them to focus on executing projects. Performed internal review on completion percentage of project deliverables, organizing the data to make it more transparent and reliable to management. ---Project manager level data is now used as a performance review metric. Led change control meetings with upper management, aiding project managers in properly communicating reasons and impact of changes. Created automatic voting system on SharePoint using a Nintex workflow which: ---Increased executive response time ---Allowed executives to log their votes via email or on directly SharePoint ---Provided a page for executives to quickly view all items awaiting their vote ---Sent reminders and notified relevant parties of approvals received

Quakertown, Pa

Served as interim Quality Assurance Manager, October - AprilHelped company pass ISO 13485, Canadian Medical Device Regulations (CMDR), and European Medical Device Directive (MDD) Notified Body surveillance audit and internal audit by:---Ensuring all certifications and procedures were prepared---Answering all auditor questions and concernsPerformed root cause analysis on audit non-conformities concerning incomplete internal audits, standards, and clinical evaluation reports, leading to:---An improved internal audit procedure---Updated standards to correct revisions---A process to ensure quality clinical evaluation reportsWorked as project coordinator with the executive and engineering team on medical ventilator and anesthesia machine 510(k) submissions for the United States and properly prepared and formatted the documents for submission. Maintained individual medical device Technical Files required for ISO certification by updating outdated documents and standards, and incorporating new 3rd edition test reports as required by the FDA.Compiled documents to meet unique registration requirements to allow for sale of Oricare devices in Columbia, Kazakhstan, Russia, Canada, Thailand, and Libya ---Dealing with the cultural and language barriersCompleted applications for FDA Certificates of Foreign Government using the new online CECATS system

Greater Pittsburgh Area

Sales Associate role providing customer assistance, receptionist and cashier dutiesUsed organizational skills to enhance the sales floor appearance and created a method for improving the presentation of clearance racks to increase sales

Sarasota, Florida Area

Sales Associate role providing customer assistance, receptionist and cashier dutiesUsed organizational skills to enhance the sales floor appearance and created a method for improving the presentation of clearance racks to increase sales

Sarasota, Florida Area

Prepared Octex for ISO 13485 certification by organization and updating all process manuals and walking the auditor through the process manuals Created a method to properly maintain process manuals, involving all parts of the injection molding manufacturing process for each productTrained Octex employee to continue the process manual updating method upon the end of my internship and created a procedure

Sarasota, Florida Area

Kept the sales floor organized and presentable, helped customers with their questions and concerns, promoted the Angel's card.

Sarasota, Florida Area

Administrative assistant responsibilities for nationally-renown architectural firm

Bs, Polymer & Fiber Engineering

Activities and Societies: Alpha Gamma Delta (Head of the homecoming display for AGD for 3 years), Gamma Beta Phi Honor & Service Society.

Education record

Activities and Societies: National Honor Society, National Merit Scholar