• Leadership position coordinating, supervising, and setting priorities for a group of 4 employees including Senior Engineers. Also had the opportunity to mentor and develop recent graduates helping them progress from Quality Techs to Quality Engineers.• Direct responsibility of Quality deliverables and management of resources in support of site projects including New Product Introduction, Design Transfer, and Global Expansion. Key achievements in this role include: o QA Site Lead for two (2) product launches. o Core Team for three (3) product launches. • Development of policies, procedures, and methods to assure products, materials and components are safe, reliable, and effective. Consistently focused on a culture of quality improvement. • Site Co-Leader for the Focus Improvement team, driving cost improvement (CI) initiatives for the site. Supported more than $300k in savings with use of Process Excellence methodologies (Six Sigma, Lean). • Responsible for the state of the Customer Complaint system for the site and all associated metrics. While in this role (2017-2019) some significant improvements were accomplished: o Achieved >50% reduction in overall Complaint Rate. o 30% reduction in Complaint Investigation turn-around-time (TAT).• Quality Risk Management SME, participated in Inspire Quality Risk Management Harmonization, led Risk Management CAPAs, Gap Assessments, and Improvements.

• Responsible for Quality Assurance support and Quality KPI’s of 3 product families (14 production lines), drove initiatives to achieve >10% reduction in Quality KPIs. • Supported site projects related to Cost Improvement, Global Expansion, and New Product Introduction. • Quality representative for the Certified Operator program initiative, leading to a successful launch.• Successful implementation of CAPAs, including a 33% reduction of major offenders for customer complaints.

• Responsible for the state of Quality KPIs on 14 production lines, driving initiatives to achieve >50% reduction in all Quality KPIs. • Core Team for new product launch including Design Transfer, process development, and equipment qualification. • Led multiple projects as a Kaizen Leader, implementing cost saving process improvements (>$50k) and reducing cycle time for quality processes.• Wrote or reviewed validation strategies and protocols, sampling plans, engineering tests, DOE’s, test method validations, GRR’s, and failure investigations for the Quality function. • Participated in vertical and horizontal assessments of QMS system, responsible for addressing issues found within Risk Management and Production and Process Control systems.• Provided support for all external audits acting as Quality lead, reviewer, and SME for post-market issues and Quality Risk Management.

· Investigated product quality complaints and process failures, coordinating cross-functional teams in the application of root-cause analysis to implement corrective actions. · Implemented a complete system for the reception, handling, and investigation of biohazard material on site.

· Prototype development of medical monitoring devices. This included front to back design of systems: biological signal acquisition, analog to digital signal conversion, signal processing, and user interface.

· Coordinated experimental studies to quantify levels stress through heart rate signal processing.