Adam Kozak
Senior Director, Quality @Edwards Lifesciences
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WORK HISTORY
Senior Director, Quality @Edwards Lifesciences
Irvine, CA, US
EDUCATION
University of Rochester
Bachelor's degree, Biomedical/Medical Engineering
SKILLS
ABOUT ADAM KOZAK
Quality Leader driving safe, reliable medical devices across NPD & sustaining functions. Lead global teams through quality laboratory (ISO 17025), design controls (ISO 13485, ISO 14971), risk-based V&V, and lean quality systems; partner with R&D/RA/PMO/Supply Chain to accelerate time-to-market while meeting FDA/EU MDR/ROW expectations. Adept at driving organizational change, financial/budgetary ownership, multi-site execution, and cross-BU portfolio outcomes.
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