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Certified Engineer in Training, ASQ Certified Six Sigma Green Belt, Certified Quality Engineer, and Certified Biomedical Auditor with ten (10) years of experience in the FDA regulated industry (solids pharmaceutical, medical device, and biotechnology industries). 

Supervision experience with manufacturing non-exempt employees and contract employees. Hands-on proven experience with non-conformances, CAPA, process procedures, compliance, regulatory knowledge (21 CFR 210, 211, 820, ISO14971, 13485 among others) and Lean manufacturing tools, among others. 

Quality mindset and process improvement oriented. Self directed with sense of urgency and attention to details.

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