Led CAPAs and NCEs to resolve product and process quality issues stemming from catheter, biologics, and combination product manufacturing linesPerformed equipment validation (IQ, OQ, & PQ) for product line remediation projects and manufacturing line improvementPerformed test method and design output validation for process and design changes to demonstrate conformance to product requirementsDrafted and routed technical reports establishing statistical evidence for the removal of test operations for products with demonstrated and sustained high performanceSupported external audits to ISO, MDR, and FDA standards and requirements

Led CAPAs and NCEs to resolve product and process quality issues stemming from applicable production linesPerformed equipment validation (IQ, OQ, & PQ) for product line remediation projectsDrafted and routed technical reports establishing statistical evidence for the removal of test operations for products with demonstrated and sustained high performance

Drafted protocols, proctored studies, and wrote reports summarizing results of Test Method Validation, Design Verification and Design Validation for Structural Heart EU MDR remediation projectsPerformed updates to DHF Risk Management documentation for Structural Heart EU MDR remediation projectsRepresented the quality discipline within Structural Heart as a project team member for continuous improvement projects and product changes

Performed equipment and software qualification (IQ, OQ, & PQ) to support product launches, equipment upgrades, process validation, and process improvementLed and reported on projects to implement process improvements and optimize facility layout, product flow, and work cellsLed and participated in projects to resolve CAPAs, NCs, and OFIs initiated by internal and external audits to ISO and FDA requirementsCollaborated with the production and product development teams to maintain and update process documentation

Coordinated and collaborated on multidisciplinary cost reduction projects with combined total annual savings in excess of $750,000Conducted internal audits to the AS9100 standard and served as a CMMI appraiser for continued organizational development Initiated, managed, and reported on root cause analysis projects focused on increasing product qualityAggregated, interpreted, & presented data to identify areas of improvement in the manufacturing processParticipated in change control board & maintained process & assembly documentation for all manufactured products

Collected guest orders, received payment, made change, and performed daily Point of Sale auditsPrepared Signature Sandwiches, Coffee, and Espresso Drinks for guests

Led project integrating tracking for bulk consumables and tooling with Aegis softwareAssisted with process improvement efforts reducing the manufacturing cost of several assembliesUpdated and evaluated manufacturing cost worksheets for current product lineCreated and updated manufacturing assembly and test instructions

Managed and directed the six employees of the Rocker Square apartments Conducted administrative duties such as budgeting, form review, and maintenance response

Conducted iterative review of process flows for circuit board and box builds within Aegis SoftwareInterpreted new engineering drawings to develop work instructions for circuit board assemblyCollected reports and sent summary statistics regarding production data to responsible engineersConversed with operators to streamline work instructions for ease of use and readability

Managed and directed the 16 employees of the Palmerton and Connolly Residence Halls Conducted administrative duties such as budgeting, form review, and maintenance response

Directed workflow and coordinated projects for Summer Conferencing at SDSM&THired, supervised, and directed nine employees in completion of designated work

Implemented and maintained a Community Development plan while living in a Residence HallWorked with fellow RAs creating immersive programs and events for over two hundred students