Sr Staff QA Engineer

$128,600 – $214,400 · Posted 11 days ago

San DiegoLast seen 9 days ago

Summary

Sr Staff QA Engineer at Dexcom leading Design Quality Engineering for material characterization, formulation science, and material-related risk management across product lifecycle. Responsibilities include establishing traceability between material attributes and device performance, leading qualification strategies for polymers, enzymes, reagents, adhesives, coatings, and membranes, applying ISO 14971 risk management, and partnering with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs. Requires 8+ years in medical device, pharmaceutical, biotechnology, or combination product development with deep expertise in material characterization, analytical chemistry, and formulation development.

Quality Assurance Adhesives Analytical Chemistry Biocompatibility Coatings Design Controls Design For Excellence Dfx Design Transfer Enzymes Formulation Development Iso 14971 Material Characterization Material Compatibility Material Science Membranes Polymers Reagents Regulatory Submissions Risk Management Software Development Lifecycle Sdlc Stability Testing Statistical Analysis Verification And Validation