QSR Training and Deployment- Provided company-wide 21 CFR 820 Quality System Regulation (QSR) training and identified and created/revised many critical procedures required by the QSRProduct Development- Collaborate with Product Management and Engineering to assess new product development and sustaining engineering prioritization and resource management.- Developed Design History Files (DHF) for four product lines (2 remediation and 2 new products) and enhanced Risk Management documents associated with the device risk profiles.Quality Assurance- Manage cross-functional workflows to gather, compile and complete product complaint/perfomance investigations per regulatory and Rauland procedural requirements.- Perform Field Corrective Action Assessments to determine FDA reportability and associated corrections/removals and requisite product holds- Executed three device removals, including the management of product hold, retrieval, and communication to the affected customers.- Coordinated 3rd-party internal audits and track/provide Rauland’s corresponding responses/actionsConducted 2015 Internal Audits as a Certified Quality Auditor- Developed the strategy and performed the remediation of CAPAs related to 483 observations associated with Design Controls, Complaint Management, MDRs, Manufacturing, Risk Analysis, Servicing, and CAPA CAPA- Collaborate with cross-functional subject matter experts to identify and assign appropriate investigation and corrective action task owners.- Facilitated, participated in, and documented CAPAs for product quality issues resulting in design and process changesComplaint Management- Assess complaint events to determine if there is a potential Life Safety event (Medical Device Report) reporting requirement.- Prepare reports/dashboards to facilitate complaint monitoring and status of complaint system effectiveness.

Research statistical and media trends to include on the weekly and gameday shows for the Big Ten Network.Collaborate with producers and analysts to derive content for shows.Edit/cut highlights and incorporate fonts over the tapes.

Supporting Medical Products NPD activities by leading efforts in requirements and risk management deliverables within the product development lifecycle.

- Analyzed data for Death and Serious Injury events from various quality inputs (including, but not limited to: nonconformances, FCA, complaints, MDR, etc.) to identify potential trends and/or systemic issues. Prepared and issued statistical trend analysis reports for the GIS Product Support Team.- Collaborated with Baxter’s lead statisticians to implement improvements to our trend analysis procedure.- Appointed Lead Auditor and approver for all trend analysis and labeling reviews submitted by our QE team, and developed an electronic audit schedule and trend analysis templates to streamline the process.- Created and implemented the In-Process Audit Procedure for GIS Infusion Pump Complaint Quality Engineering Tasks and assisted in the overhaul of the Quality Engineering Tasks for GIS Infusion Pump Complaints procedure.- Supported a Green Belt project regarding the identification of wastes and opportunities to bring forth process improvements in our team’s process through a value stream mapping project.

Worked in Device Technical Operations supporting medical device development through interaction with marketing, manufacturing, and medical divisions.Evaluated Hospira’s existing products against top competitors’ products from marketing, engineering, and aesthetic perspectives, highlighting competitive strengths and suggesting areas for improvement. Conducted a cost reduction analysis for the tubing used in medical devices. The conclusions were accepted and utilized by the project team to determine whether or not a cost reduction and/or performance improvement would result in a tubing commodity/I.V. filter change for Hospira.Submitted and approved a specification change request for material commodities through SAP.

Member of a technical group supporting existing products within the pharmaceutical and medication delivery industry.Conducted three competitive analyses with independent hands-on experimentation of disposable intravenous sets and components. Presented results to senior management represented by marketing, device development, and product development.Resolved development protocol inconsistencies with outsourced manufacturer of in-line filters to meet the needs of Hospira’s client, Filtertek, and calmed their concerns.

Led project to resolve solder material problems for Flip Chip Ball Grid Array supplied to Cisco Systems. Managed project scheduling and purchasing and led weekly web conferences between TI and Cisco.Implemented two new reliability tests with NTK Technologies (a TI supplier) per request from Cisco– the shock/vibration test and the four-point bending test.Operated independently in a laboratory, performing cross-sectioning and failure mode analyses.