Review Quality System documentation (analytical/medical records, batch records, protocols, reports, environmental monitoring data, Device Design History Files, laboratory data, etc.) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and GMP/GLP/QSR and internal requirements. Develop, execute, and review validation lifecycle documentation, including but not limited to SOPs, Validation Master Plans (VMPs), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specifications, FAT/SAT, and DQ/IQ/OQ/PQ/PV protocols and reports.