Barbara Davoux Email & Phone Number

Lake Forest, Il

-Responsible for the completion of immunodiagnostic assay complaint investigations-Authored customer complaint investigation testing plans for the in-house Analytical Quality Assurance Lab-Supported complaints for the domestic market as well as European and Japanese markets-Interfaced directly with customers via written correspondance and phone conversations-Conducted follow-up surveys with customers to determine their satisfaction on the thoroughness of the complaint investigation and timeliness of completion

-Subject matter expert for Thyroid Assays (Free T4, Total T4, TSH) across multiple Abbott Diagnostic immunoanalyzer platforms-Responsible for pre-market and on-market quality support of Thyroid assays-Package insert review and approval for diagnostic assays-Quality Lead for multiple Expanded Investigations which used the Six-Sigma Problem Solving (DMAIC) method to determine root cause

•On-market quality support of four ARCHITECT Glycoprotein assays (LH, TSH,FSH, β-hCG).•Provided quality review of customer complaints, equivalency and qualification packages, and testing protocols •Quality remediation change request reviewer as part of the remediation effort for the ADD Consent Decree•Quality Lead for the Expanded Investigation for ARCHITECT Free T4 and Total T4 assays

• Contributed to the development/redevelopment of the ARCHITECT Total β-hCG , ARCHITECT Phenobarbital, ARCHITECT FT4 Assays from feasibility through launch of assay to market• Conducted design verification testing and other critical studies. Summarized and presented data for multiple Feasibility, Research, Pre-Clinical, 510K Submission, and Pre-Market Design reviews.

M.S., Biology

Research for my Master's thesis was performed at Case Western Reserve University in Cleveland, OH. The thesis summarized my work which was.

B.S., Biology Major, German Minor