Vrushank Shah MBA,CQE,CQA

Greater Chicago Area United States

Quality Engineer II at Lake Region Medical

Medical / Health Care / Pharmaceuticals

• Seven years of work experience in implementing quality requirements in cGMP and FDA regulated industry. • Six years of product knowledge related to medical devices and ISO 9000, 13485 and 14971 standards. • Certified Quality Engineer (CQE) with proven ability in design controls, risk assessments, gage R&R, GD&T, SPC and DOE. • Certified Quality Auditor (CQA) to have co-led and supported FDA, Saudi Arabia, TUV, EU, Client, Supplier and Internal audits. • Excellent written, communication, interpersonal and problem resolution skills. • Work attitude that exhibits strong attention to detail, result and decision making. • Possess strong skills in Microsoft Office, Lean Six Sigma (DMA...