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Skills:
Problem Solving, risk assessments, Iso 13485, continuous improvement tools, SCAR, Fmea, Non-conformance Handling, FDA 21 CFR Part 820, Risk Management, Capa, component qualification, supplier management processes, audits
Skills:
Good Distribution Practices, Iso 14971, Iso 13485, Root Cause Analysis, 21 CFR Part 820, Internal Auditor, cGMP regulations, Capa, Risk Management, MDSAP, Change Control, Iso 9001, Microsoft Office Suite, Statistical Analysis Tools
