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Fady Khalla
Device Project Lead
Fady Khalla is a Certified Six Sigma Green Belt Biomedical Engineer with a solid background in medical device quality engineering and document control.
With three years of experience in the medical device industry and two years of research in microfluidics and cardiovascular engineering, Fady brings a wealth of expertise to the table.
His skills include outstanding research abilities, meticulous planning, and excellent technical writing and presentation skills.
Fady has extensive knowledge of Good Manufacturing Practice (cGMP), Quality System Regulations (QSR), and FDA regulations.
He is well-versed in implementing and auditing ISO standards such as ISO 13485, ISO 14971, IEC 62304, and EU MDD 93/42/EEC.
Known for superb communication and organizational skills, Fady can work effectively both independently and as part of a team.
His strengths lie in attention to detail, process improvement, workload prioritization, and efficient resource utilization.
Fady Khalla holds a Master of Science (MS) in Biomedical/Medical Engineering from the New Jersey Institute of Technology, where he achieved a perfect GPA of 4.0.
He also completed a Bachelor of Science (BS) in Biomedical/Medical Engineering at Rutgers, The State University of New Jersey-New Brunswick, with a GPA of 3.6.
Fady has held roles at reputable organizations like Merck, where he served as a Project Lead and previously held positions as Sr. Specialist in Design Controls, Risk Management & Human Factors, and Engineering Specialist in Design Control and Risk Management.
Prior to Merck, Fady worked as a Quality Engineer at Milestone Scientific Inc. and as a QA Inspector/Document Control Specialist at Omnyx, LLC - a joint venture between GE Healthcare and UPMC.