Ready-to-go regulatory content
Access pre-configured templates and documentation for faster and smoother FDA & ISO compliance.
Powerful eQMS
Use Qualio to build a world class electronic quality management system, from documents and design controls to training and events.
Quality assurance experts
Work with our team of seasoned quality experts to ensure you meet - and exceed - your QA goals every time.
OUR QUALITY TEAM
Meet your quality support team
The Qualio+ team combines commitment to your
success with a wealth of life science quality experience.
Kelly leads Qualio’s in-house quality team and spearheads our Qualio+ offering. Kelly has built over 20 years of experience working with quality teams at Abbott, Sandoz, Cochlear and more, before becoming Qualio's Director of Quality.
Kelly Stanton
Director of Quality
Jerry has 15+ years of experience in pharmaceutical, biotechnology and diagnostic laboratory environments, and joined Qualio after 3 years consulting for the CDC.
Jerry Adatsi
Senior Quality Specialist
Ezra brings nearly 10 years of quality experience to his role at Qualio. He’s led teams across the industry through FDA compliance journeys, rigorous audits and cloud-based QMS builds.
Ezra Kelderman
Quality Engineering Manager
Meg has amassed over a decade of experience as a QA/RA and compliance professional, with a range of cross-functional skills and knowledge spanning from non-profits to start-ups.
Meg Sinclair
Senior Quality Specialist
Amanda has almost 10 years' experience in pharmaceutical, biotechnology and medical device environments, in roles from engineering to quality assurance. Before joining Qualio, Amanda was a QA Manager at an SaMD start-up.
Amanda Inks
Senior Quality Specialist
Molly brings 8 years of quality knowledge to the Qualio+ team, which she's gained from working in the pharmaceutical, medical device and laboratory fields. Molly is particularly experienced with FDA, HPRA, MDSAP and ISO 13845 audits.
Molly Calvey
Senior Quality Specialist
Sumatha has 18 years of industrial experience in quality assurance and regulatory affairs. Sumatha has built quality management systems for medical device, pharmaceutical, bioanalytical, pre-clinical and clinical study companies, and is also a seasoned auditor for ISO 13485, ISO 9001 and ISO 17025.
Sumatha Kondabolu
Senior Quality Specialist