Gilbert Jimenez Email & Phone Number

Chatsworth, California

● Applied problem-solving methodologies, risk analysis identification, prioritizing, communicating, audit preparations and resolving quality issues relating to the manufacture of Urine Analysis Instruments using Kaizen and Six Sigma/Green Belt tools ensuring compliance to CFR 820 & ISO 13485 ● Reliability validation to new product design-writing and executing protocols cross functionally with Engineering and Quality Management as it associates to change control, documentation issuance, and product specification● Managed calibrated measuring devices, reviewing and approving Out of Tolerances (OOTs) ● As a Certified Auditor lead audits for medical devise facility as it relates to CFR-820 and ISO-13485. ● Supply Management of incoming stock for Receiving/Inspection using statiscal analysis placing items on Dock to Stock status or removing as necessary as per Six Sigma and CFR requirements● Led Quality Assurance team ensuring with daily communications as they relate improvement projects ● Completed Audits to International Field Service Engineers to CFR

Audit and improve compliance issues in biopharmaceutical.Led team of 5 Quality Associates on multiple shiftsContinuous Improvement Leader using Six Sigma/Green Belt, LEAN, DMAIC methodologies with cross functional teamsChange ControlProduct Release management

Greater Los Angeles Area

Manage process for non conformance reports (NCR)Led Quality Improvement Projects using DMAIC, Value Stream mapping and Standard Work toolsFirst line quality approval for non conformances and corrective actionsRecommended and participated in cross functional teams for CAPA closuresReport Quality Metrics to Senior Mgt TeamApprove Out of Limits from Microbiology Investigated and wrote reports associated to customer complaintsDesigned, wrote and approved validation protocols for a CFR regulated Pharmaceutical process including the process equipment and facility. Process validationCleaning validationProcess parameters evaluated using Failure Mode Evaluation AnalysisEstablishing statistical analysis for decision making tools for bio tech processing