Sharifa Lewis

Specialize in data-driven post-market surveillance and performance trending to monitor complaint rates and identify potential signals. Translate complex dataset outputs into insights that support risk assessments and CAPA/regulatory decision-making.

Support design verification testing activities for FDA 510(k) submissions by writing and reviewing test protocols and reports. Coordinate with regulatory, quality, and engineering teams to produce accurate, audit-ready documentation.

Analyzed returned medical devices and investigated complaints to identify potential quality issues and root causes of device failures. Collaborated cross-functionally to determine corrective action needs and maintained product performance engineering lab audit support by ensuring adherence to lab protocols.

Maintained biological sample organization and handling for laboratory analysis while following lab protocols, sanitation standards, and testing procedures. Supported compliance with applicable regulations and ensured samples were prepared for analysis correctly.

Provided consistent, personalized customer service while supporting facility operations. Assisted patrons by greeting guests and granting facility access in accordance with facility processes.

Performed clerical duties to maintain an equipment checkout system and administrative processes for academic equipment reservations. Helped improve customer satisfaction through reliable front-line support.

Maintained drosophila cultures by preparing fresh media and regularly cleaning glassware to sustain ongoing research. Supported day-to-day lab operations with attention to routine procedures and lab organization.

Earned an M.S. in Engineering Management at Trine University, completed in May 2026.

Earned a B.S. in Biomedical Engineering at the University of Arkansas, completed in May 2021.