Lead quality engineering support for our company's first 510K submission.

• Assist quality team with receiving/releasing material to production/distribution center, evaluate inspection records, and assist shipments to sterilization.• Manage CER environmental monitoring, execute and document process test reports, perform process statistical data analysis.• Manage quality related instructions/documents such as NCRs, CAPAs, deviations & complaint reports. • Review and approve LHRs/first articles/equipment profiles/CRs and perform SAP related transactions. • Perform in-process and final inspection, validate processes and perform characterization studies to improve yields or identify specifications, support R&D with performing investigations for complaint/returned devices. • Increased yield rate for manufacturing by performing various tests and supported the manufacturing floor from the quality side.• Reduced on-line and incoming rejects & validated/qualified equipment for testing in IQA.• Improved NCR/CAPA closure time by over 70%.

-Assisted quality manager w/audits, documentation control, management review, quality control, CAPA & NCMRs; Apply statistical methods to data analysis (complaint trends, validations, risk analysis)-Collaborated with engineers and project managers to ensure medical device production followed ISO 13485/FDA regulations, approved suppliers for Duke projects, performed audits with vendors, managed controlled logs for Duke Empirical/Extrusion, control and improve manufacturing procedures

-Managed lab portion of class (logic design); gave quizzes, lectures, graded HW/lab work and assigned official lab grades-Held office hours to help students; control of lab equipment and class website

-BS thesis written on the mechanical properties of Muscle Stem Cells and their substrates using Atomic Force Microscopy. -BS thesis won "best senior design" award for the bioengineering department at SCU.

-Studied mechanical and electrical properties of Muscle Stem Cells (c2c12) under viable conditions -Study mechanical and electrical properties of carbon nanofibers using Atomic Force Microscopy-Trained on AFM and SEM by NASA researchers on mech/bio design, performance and modeling of atomic and electronic microscopes for biological samples