Significant experience in biomedical and technology industries with emphasis on quality systems, process improvement, regulatory affairs, compliant software and process development, project management, healthcare data, and clinical skills.
Working knowledge in FDA QSR & cGMP, EU MDD, GAMP, ICH, GHTF, Lean Sigma tools, ISO 9001/13485/14971/17025, DSHEA, HACCP, MDDS, and assorted standards.
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