From Theory to Practice: A Profile on Seraph’s Advanced Quality Engineer

seraspec

From Theory to Practice: A Profile on Seraph’s Advanced Quality Engineer

Lamees Almawri – Advanced Quality Engineer

Seminar at Wayne State University

While completing her Masters in Biomedical Engineering at Wayne State University, Lamees Almawri had the opportunity to take a two semester graduate course sequence on smart sensors with Seraph Chief Science Officer, Dr. Greg Auner. It marked the beginning of a working relationship that would become crucial for Seraph Biosciences in the future. The first semester was a theoretical discussion on the application of smart sensors and microsystems to the detection of bacterial pathogens. When these studies were completed, Lamees along with a group of colleagues had the opportunity to fabricate the design and development of an actual sensor at Wayne State’s Smart Sensors and Integrated Microsystems (SSIM) laboratories.

Broad Experience in Quality Management

Upon graduation, Lamees wanted to leverage her academic experiences to receive broad exposure to real world product development processes. At Beaumont Health System, Lamees assisted investigations of medical device incidents and helped with reporting adverse events and device malfunctions to the FDA for regulatory compliance. She then went on to become a test lab technician at Stryker Corporation and Quality Specialist at Healthmark Industries. In these roles, Lamees performed verification testing and implemented quality activities necessary to manufacture devices ranging from surgical instruments to sterility assurance products. It was at this time that her career came full circle back to the labs at SSIM when she was recruited by Seraph to work as an Advanced Quality Engineer.

Joining Seraph Biosciences, Inc.

Since Lamees joined Seraph’s core management team, she has developed and refined Seraspec’s quality management system to ensure compliance with FDA and ISO 13485 requirements. Over the last few months her focus has centered around readying the Seraspec® platform for FDA Emergency Use Authorization (EUA) through the NIH’s RADx program. “Seraph’s participation in the RADx program emphasizes the importance of meeting the quality system requirements for premarket approval via EUA”, said Almawri, “The goal is to ensure that Seraph has the appropriate controls for this premarket approval and eventual commercialization of Seraspec®”. The team at Seraph Biosciences is thrilled to have Lamees back home in Detroit and will rely heavily on her expertise to bring Seraspec® to market.