Sr QA Engineer
San DiegoLast seen today
Summary
Sr QA Engineer leading complex quality investigations, root cause analysis, CAPAs, and NCMRs at a regulated medical device company (Dexcom). Drives Quality Management System excellence through continuous improvement methodologies (Six Sigma, Lean, process capability analysis), owns validation and qualification strategies for equipment/processes/software, and guides design transfer and commercialization from development to high-volume manufacturing. Requires advanced quality engineering knowledge, hands-on technical aptitude, proficiency with data analysis tools (JMP, Excel), and cross-functional leadership across R&D, Regulatory, Manufacturing, and Engineering teams.
Quality AssuranceAqlCapaCommercializationCpkData AnalysisDesign TransferExcelFmeaGage R RIq Oq Pq PvJmpLean ManufacturingNcmrPpkProcess Capability AnalysisProcess ValidationQuality Management SystemsRisk ManagementRoot Cause AnalysisSampling PlansSix SigmaSoftware V VStatistical AnalysisTest Method Validation