Jay Mccarthy Email & Phone Number

Waukesha, Wi, Us

Chicago, Us

Chicago, Us

QA Director for the Global Healthcare Project Management (Installation) Organization supporting 700+ employees globally and ensuring compliance to ISO 13485 and global medical device regulations. Responsible for developing and maintaining quality plans and procedures, leading effective management reviews with executive senior leadership, executing audit plans, CAPA boards, training plans, concessions and deviations, computerized system validation, and supplier controls.

Chicago, Us

• Quality Manager for Service Operations and Install organizations, supporting over 550 employees globally. Responsible for developing and maintaining quality plans, leading management reviews, audit plans, CAPA boards, training plans, design controls, computerized system validation, and supplier controls.• Global Program Manager for Service Documentation Quality since March 2012, leading service record quality improvement plans across global Service Operations and Product Surveillance teams. Responsible for managing and reporting weekly, monthly, and quarterly metrics for Service Record Quality and driving global continuous improvement and CAPA plans. Developed and deployed multiple global training programs on service record quality and test and inspection requirements. Led service deployment for new complaint handling system in 2014 and 2015.• QA Leader on Business Development team for service acquisition in 2012 and 2013. Responsible for investigating and identifying compliance risks and developing post-acquisition remediation plans and quality system integration activities.

Chicago, Us

• Led the Global Ultrasound Complaint Handling Team with 14 direct reports across 10 manufacturing sites in the US, Europe, Asia, and Middle East. Ensured timely and complete complaint evaluation, investigations, adverse event reporting, and complaint trending. Responsible for hiring new talent, performance reviews, coaching, succession planning, and developing talent.• Developed organizational model and reorganized roles and responsibilities to optimize operations and ensure consistency, compliance, efficiency, and effectiveness in the global team.• Acting Life Support Solutions Product Surveillance Manager from Oct 2010 – June 2011 while maintaining responsibilities for Ultrasound. Managed 11 indirect reports in Madison, WI covering 5 manufacturing sites globally.

Chicago, Us

• Led Complaint Handling Units in Diagnostic Ultrasound and Cardiovascular Ultrasound segments, ensuring timely evaluation, investigation, and closure of complaint records. Drove process improvements to reduce both backlog and complaint cycle times by 50% in 2007. Developed and mentored new Complaint Leader in order to take on additional responsibilities.• Authored Global Clinical Systems Complaint Handling Work Instructions: Developed Process map, Simplified process to drive backlog reduction and efficiency, developed complaint templates to drive consistency, Co-developed Training Material and trained global Complaint Handling Units.• New Complaint Handling System Development Program Team: utilized lean principles to develop complaint records, influenced simplification in complaints & risk management processes, and made complaint program decisions representing Clinical Systems businesses.• Stretch assignment as Documentation Leader for Research Park: wrote and implemented local procedures, led the Document Review Board and developed templates for Document Change Requests, ensured compliance in document changes including implementation plans, obsolescence, and dependencies.

Chicago, Us

• Complaint Coordinator for XRD leading evaluation, investigations, and CAPA’s for digital x-ray detectors, chillers, and power supplies. Interfaced with Mammo, Vascular, and X-Ray modality systems engineering teams for complaint related action plans.• Supplier Quality Leader for two detector chiller vendors leading monthly quality reviews, supplier audits, and driving supplier CAPA’s resulting 50% reduction in warranty costs for 2004, 2005, and 2006.• Lead Program Integrator for new Flex Supplier Program for x-ray detector designs. Developed program plan and coordinated engineering, sourcing, and manufacturing teams through supplier selection of 70 vendors to the successful qualification of new flex circuit vendor.• Led Six Sigma Projects and Design of Experiments on hot bar solder process, fiber optic transceivers, and flex circuit 64-channel leakage quality issues to successful resolution and demonstrated CAPA effectiveness.

• Led experiments on NSF grant for developing Neural Network controller for stabilized control of LoFLYTE unmanned, aerial aircraft. Co-author in publication of results: “Controller Design via Adaptive Critic and Model Reference Methods” in International Joint Conference on Neural Networks (IJCNN) 2003.• Developed Neural Network, Fuzzy Logic, and Genetic Algorithm models in Matlab to further studies in Artificial Intelligence in engineering functions, primarily with respect to control systems.

Newark, Delaware, Us

• Sales Engineer responsible for $7MM territory in Oregon, Idaho, and southern Washington for wire, cable, and materials for printed circuit boards and flex circuits.• Developed technical solutions to expand with current customers and developed new relationships with key semiconductor customers for Automated Test Equipment.

Bs, Chemical Engineering

Ms, Electrical Engineering