Regulatory content
Pre-configured templates and pre-written documentation for FDA & ISO compliance.
eQMS
Pre-configured templates and pre-written documentation for FDA & ISO compliance.
Quality assurance experts
Pre-configured templates and pre-written documentation for FDA & ISO compliance.
OUR QUALITY TEAM
Meet your Quality Advisors
Our best-in-class software is backed by a best-in-class teamcommitted to your success.
With 20+ years of experience, Kelly leads Qualio’s in-house Quality team and spearheads our Qualio+ offering. Kelly has worked with Quality teams at Abbott, Sandoz, Cochlear, and more.
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Kelly Stanton
Director of Quality
Jerry Adatsi has 15+ years of experience in pharmaceutical, biotechnology, and diagnostic laboratory environments. He joins Qualio after spending 3 years consulting for the CDC.
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Jerry Adatsi
Senior Quality Specialist
Ezra brings nearly 10 years of experience in Quality to his role at Qualio. He’s led teams across the industry through FDA compliance, audits, and build outs of full cloud-based Quality Management Systems.
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Ezra Kelderman
QA Engineering Manager
Meg has 10+ years as a Quality Assurance, Regulatory Affairs, and Compliance professional with a range of cross-functional skills and experience spanning nonprofits to startups.
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Meg Sinclair
Senior Quality Specialist
Amanda has almost 10 years of experience in pharmaceutical, biotechnology, and medical device environments in roles from Engineering to Quality Assurance. Most recently Amanda was a Quality Assurance Manager with an SaMD startup.
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Amanda Inks
Senior Quality Specialist
Molly brings 8 years of quality knowledge gained from working in the pharmaceutical, medical device and laboratory fields and has experience with FDA, HPRA, MDSAP and ISO 13845 audits.
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Molly Calvey
Senior Quality Specialist
Sumatha has 18 years of industrial experience in Quality assurance, Regulatory Affairs. Established quality management system for Medical Devices, Pharmaceutical Analytical, Bioanalytical, Pre-clinical, and Clinical studies. Sumatha is also an auditor for ISO 13485, ISO 9001, and ISO 17025.
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Sumatha Kondabolu
Senior Quality Specialist