Danielle Kessens

Software Quality Assurance @Eli Lilly and Company

Greensburg, IN, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Sep 2023 — Present

Software Quality Assurance @Eli Lilly and Company

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EDUCATION

N/A

Purdue University

Bachelor of Science (BS), Electrical Engineering Technology

SKILLS

IsoFdaCross-Functional Team LeadershipSupplier QualityManufacturingQuality SystemProduct Lifecycle ManagementIntegrationProject Portfolio ManagementTest ValidationSix SigmaProduct LaunchOracleRequirements AnalysisValidationAgile MethodologiesErpExtensive Knowledge of the 21 Cfr Part 820 and 21 Cfr Part 11Iso 13485SdlcRoot Cause AnalysisItil CertificationMedical DevicesCapaOracle Agile PlmTestingItilQuality ControlSix Sigma Green Belt CertificationQuality Assurance

ABOUT DANIELLE KESSENS

15 years of experience developing and supporting the Agile PLM (Product Lifecycle Management) system. Effective at translating business needs into detailed requirements to provide solutions to address inadequacies. Actively engage stakeholders throughout a project. Deliver on-time implementation of changes. Demonstrate strength in the validation process. A competent professional that is experienced working in FDA regulated industries. Six Sigma Green Belt and ITIL certified.Specialties: Oracle Agile PLM, SDLC, SQL, experience in FDA regulated industry

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