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- Developed and maintained quality standards and protocol for manufacturing finished product- Utilized Six Sigma tools and methodologies as Project Leader for various cost reduction and quality improvement projects- Devised and implemented inspection/testing methods for products and production equipment- Utilized statistical analysis techniques to assess processes and testing outputs- Supported manufacturing continuous improvement and development as the quality team member for validation including IQ, OQ, PQ and test method validation- DOE and comparison testing to support development engineers in the development of compliant test plans and reports- Risk assessment for manufacturing and development including FMEA- Developed solutions for monitoring and reporting as well as taking appropriate action based on quality metrics- Led CAPA investigations and implemented corrective actions- Led the investigations of non-conforming materials, including containment and root cause determination

- Hands-on device validation testing with physician input on new products- Project Lead on internal inventory restructuring. Responsible for optimization planning, implementation, and improving efficiency of raw material inventory and final product inventory. - Project Lead on internal product introduction into Quality System. Responsibilities included product number assignment, traceability optimization, writing Standard Operating Procedures and Bills of Materials.- Project Lead on an OEM design. Responsible for communication, budgeting, scheduling, design history file.- Project Lead on ERP and QMS software upgrade research under direction of Chief Operations Officer. Responsible for researching various vendors, communicating with vendors, evaluating demonstrations, and analyzing cost comparisons.- Project Team Member on three other projects to design and manufacture OEM custom medical devices. Responsibilities included design input, communication, collaboration, organization, sourcing raw materials, manufacturing workflow, and clinical design validations.- Quality System and regulatory standards involved in medical device testing, manufacturing, and sterilization- Capital Equipment Process Validations: Responsible for writing protocols, collecting data, writing final reports for IQ, OQ, PQ. Specific validations that were successfully carried out include the Cleanroom, Tensile Tester, and Steam Autoclave.- Exposure and hands-on experience on the manufacturing floor with various machines such as: injection mold, extrusion, thermal tip, precision spring winder, laser cutter, grit blaster, ultrasonic weld, micro EDM.