Manufacturing level leader with year-after-year success leading change and driving favorable business metrics with cost reductions and process improvements; using business savvy and comprehensive knowledge of 6 sigma, lean and manufacturing principles to drive structural and behavioral change plant-wide targeting manufacturing as a core competency for the company; highly successful in building relationships with decision-makers at all levels of the organization, seizing opportunities in critical problems areas and delivering on customer commitments through sustainable business results.
Specialties: Medical Devices, ISO 13485, 21 CFR 820, Multi-Million Dollar Capital Writing, Validation Studies (Process Capability Studies, IQ/OQ/PQ), Risk Analysis (pFMEAs, Control Plans, etc.)
