Melinda Sogo, Senior Medical Device Consultant at PQE Group, discusses her 20+ years of experience in quality and regulatory across Medical Device, Pharma, and IVD, and her current role focusing on quality management systems and Software as a Medical Device.
By PQE Group | July 29, 2025
1) Please introduce yourself to our audience by looking back at your education, training, and career path.
I have a BA in chemistry with an emphasis in Biochemistry from the University of Northern Colorado and an MBA in Business Management from American Intercontinental University. I started my career in the laboratory performing microbiology, molecular biology, and cellular biology research studies, including working with a company that developed microbial-resistant surfaces based on the surface structure of shark skin. I found my passion for quality and regulatory while working in the labs, and I now have 20+ years of experience in quality and regulatory which spans GCP, GLP, and GMP. I have worked in Medical Device, Pharma, and IVD as both a quality and a regulatory expert.
2) Can you share more about your specific role at PQE Group? What are your main goals in this role, and what’s your favorite part about your job?
I recently joined PQE Group as a Senior Medical Device Consultant with its Medical Device Team; I am a subject matter expert in medical device, pharma, and IVD quality management systems, regulatory, and Software as a Medical Device, including AI/ML devices. My main goal is to supplement and support the other members of the Medical Device Team and provide my expertise for quality management system start-up and remediation, and Software as a Medical Device.
My favorite part of my job is identifying each client’s specific needs. I approach each project like a logic problem. The clues are there – we familiarize ourselves with them – and it is our job to figure out the exact solutions for what the client needs, even (especially) if the client does not know what those answers are. Once we discover them, our jobs are to identify solutions, resolve those problems, and lead the client to a successful resolution.
3) Can you tell us more about why companies should consider partnering with PQE Group and what type of services you offer to your clients?
PQE Group hires talented individuals with vast areas of expertise to ensure that our teams provide solutions based on first-hand industry knowledge. Our Medical Device group includes former FDA employees, experts from small and large industry businesses, and team members that have experience in various areas of quality and regulatory. In addition, we can lean on our Centers of Excellence to supplement our needs in support of our clients. The interactivity and collaboration between different groups that I have seen in my short time with the company has been helpful and refreshing.
4) Consulting is becoming a popular career path, particularly for scientists and medical professionals. What, in your opinion, are the top skills needed to be successful in a life science-focused consulting role?
Be willing to learn something about everything while figuring out what you have a passion for, and be willing to pivot when the world perspective pivots. When I started out my career, I wanted to be a bench scientist and become an expert in bench techniques. Now, I am learning all about software and AI/ML…I never thought that would be my passion, but here I am, 20 years into my career, learning something new and exciting. I still keep up to date on the latest bench techniques, and I totally geek out when someone brings out pipettes and lab equipment, but I know the future for me lies in the technology sector.
5) Now for the fun question – what is the best piece of advice that you’ve ever been given?
Don’t be afraid to try something new. You may fail, but at least you tried it, and you will learn something about yourself in the process.
