Staff QA Engineer

$111,100 – $185,100 · Posted 9 days ago

San DiegoLast seen 7 days ago

Summary

Staff QA Engineer role at Dexcom leading quality engineering for high-volume manufacturing automation, design control, and process validation. Responsibilities include interpreting FDA 21 CFR 820 and ISO 13485 requirements, architecting validation strategies, driving design transfer for commercial deployment, leading complex investigations and CAPA initiatives, and mentoring cross-functional teams. Requires deep expertise in root cause analysis, Six Sigma, process validation, statistical analysis, and data-driven decision-making across global sites.

Quality Assurance Capa Cpk Design Control Design Transfer Excel Fda 21 Cfr 820 Fmea Iso 13485 Jmp Lean Manufacturing Nonconformance Management Ppk Process Capability Process Validation Root Cause Analysis Sampling Plans Six Sigma Software Validation Statistical Analysis Test Method Validation