Technical Service Manager for the US. Responsible for Technical Service training. Service equipment in the Nashville area.

Have worked extensively in the Medical Device industry for Fresenius Medical Care North America (FMCNA). Applied my talents and skills in different areas from Production Technician, Technical Services (hands on and management), Production Management, R&D to Quality Systems (CAPA Review Board member and participated on CAPA remediation team after FDA (Food and Drug Administration) warning letter – Plant Concord concluded a 3 week FDA audit without observations). In addition, I worked on Engineering changes (DMR, DHF, Bill of Material updates/changes) requested by our main supplier Fresenius Germany as well on several product improvement teams as a knowledge resource (product knowledge and as LSS (Lean Six Sigma) Black Belt with project management advice and problem analysis. Familiar with the QSR (Quality System Regulation) CFR21 Part 820, ISO 13485 and their interpretation.Over the last 10 years I focused on Continues Improvement and Operational Excellence. .I coached Yellow Belts and Green Belts through training (MoreSteam.com online training) and through their projects to reach certification. In addition, I participated on several CAPA teams with my product experience, with Root Cause Analysis skills and with making data based decisions.I am excited to start a new career applying my vast knowledge and making a difference your company!

Led and coordinated the Lean Six Sigma efforts for the manufacturing site. Worked with area leaders to identify projects and employees for LSS training and certification. Coached employees through training and certification. CAPA was added and later and replaced by supplier projects. Managed and implemented supplier design changes from Fresenius Germany, prioritized projects, managed the seven most urgent projects, and worked on forty five other projects as time allowed• Trained and coached Lean Six Sigma Yellow Belt/Green Belt through certification improving operations.• Led project selection sessions for operational areas. Coached and participated on project teams that reduced field failures by 59% (reduced returns by 1000 a Month saving $1,000,000/Month).• Worked on projects directly improving bottom line results in multiple areas including: Quality Systems, R&D, Sustaining Engineering, Production, Refurbishment, Returned Goods, Warehouse, Purchasing, and Field Service.• CAPA (Corrective and Preventive Action) review board member, contributed on CAPA teams with detailed product knowledge and coached teams on Root Cause Analysis and Project Management.• Managed and implemented supplier design changes from Fresenius Germany, prioritized projects, managed the 5 most urgent projects, and worked on other projects as time allowed.• Participated in Supplier Quality audits.• Trained cGMP (CFR21 part 820).• Trained (quality) engineers, guided pant tours.

Led and managed 7 departments with constant changing goals by cross-training and shifting manpower. Managed productivity, quality, employee discipline, hiring and team budget. • Increased output up to 30% annually over 10 years with little or no increase of manpower by working smarter not harder.• Managed 7 direct reports and 200 employees (with increasing responsibility.)• Discrepant Material Review Board Member (MRB)PREVIOUS EXPERIENCEAssistant Project Manager R&D, 2008H Hemodialysis Machine development• Modified and upgraded the Hydraulic assembly. The Hydraulic is an electro-mechanical assembly containing solenoid valves, pumps and electronic sensors. Technical Support Manager• Led and expanded Technical Support Team as the company grew, provided service to the local service area and managed a team of seven providing Technical phone support for US and Canada.Test and Calibration Technician • Tested, calibrated, troubleshot, and repaired Hemodialysis Machines, trained employees in Germany and USA.