Staff QA Engineer

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

San DiegoLast seen 9 days ago

Summary

Staff QA Engineer at Dexcom leading manufacturing quality engineering and design control for high-volume medical device automation. The role requires deep expertise in FDA 21 CFR 820 and ISO 13485 compliance, design transfer strategy, process validation, and CAPA/MRB leadership across global manufacturing sites. You will mentor cross-functional teams, drive systemic quality improvements, and represent the organization during regulatory inspections, with strong emphasis on data-driven decision-making and risk-based design methodologies.

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