Skills:
developing FMEAs, risk analysis, control plan, Process flow diagrams (PFD), chemistry, non-conformance report, created corrective and preventive action plan, involved heavily in process validation and verification, managed incoming inspection documents and personnel, traceability techniques, 8D supplier corrective action reports, Part inspection plans PIP, CAPA initiations , complaints analysis, supplier testing equipment, Product Management, engineering Change Order, DMAIC: Six Sigma, FDA / ISO9001, ISO 13485 / UL regulation, Root cause analysis, Process Quality Planning, Failure investigation, 21 CFR 820 QSR, Inspection Planning, Statistical Techniques, Sampling Principals, Inspection and Testing, Capability Studies, Supplier Audits