Shelly Moore, ASQ CMDA, CMQ/OE, CQE, CCT, CQIA
Shelly Moore, ASQ CMDA, CMQ/OE, CQE, CCT, CQIA, is a seasoned quality and regulatory affairs executive with extensive experience in the medical device, OTC, and healthcare product industries. She currently serves as Senior Director of Quality Assurance and Regulatory Affairs at S2S Global, where she leads global compliance strategies, supplier quality management, and regulatory readiness across domestic and international operations. Shelly holds multiple certifications, including Lean Six Sigma Master Black Belt, Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Certified Medical Devices Auditor, and Certified Six Sigma Black Belt, reflecting her deep technical expertise and commitment to operational excellence.
Over her three-decade career, Shelly has progressed from an entry-level lab technician to senior leadership, mastering quality and regulatory affairs while overseeing multiple departments, including quality assurance, regulatory affairs, customer service, and IT. She has managed large-scale compliance transitions, developed quality monitoring programs across global supplier networks, and successfully implemented process improvements that enhance operational efficiency and maintain rigorous quality standards. Her ability to combine analytical problem-solving with strategic leadership has been a cornerstone of her success.
Beyond her professional accomplishments, Shelly is deeply committed to family and community. She enjoys spending time with her four-year-old grandson and is passionate about extreme couponing, which she uses to support friends, family, and her community by providing essential items such as diapers, wipes, and household goods. Her career and personal pursuits reflect a consistent dedication to excellence, service, and continuous improvement, both in her professional life and in the ways she gives back to those around her.
• Certified Calibration Technician
• Certified Manager of Quality / Organizational Excellence
• Certified Quality Engineer
• Lean Six Sigma Master Black Belt
• Harvard Business School Online
• Capella University
• ECPI University - AS
• Warren National University - BS
• North Carolina State University
• American Society for Quality
What do you attribute your success to?
I attribute my success to a strong work ethic, adaptability, and a commitment to continuous learning. Being analytical, detail-oriented, and solution-focused along with earning advanced certifications such as the Six Sigma Black Belt and Certified Quality Engineer has enabled me to excel and step confidently into expanding leadership roles. I entered the industry out of necessity while completing my engineering degree, and what began as an entry-level lab technician position evolved into a three-decade career in quality and regulatory leadership. Over the years, I have mastered the complexities of quality assurance and regulatory affairs and advanced into senior leadership, where I now oversee quality assurance, regulatory affairs, customer service, and IT following my company’s acquisition. Among my most meaningful achievements are earning my Six Sigma Black Belt and using it to drive major process improvements, leading large-scale compliance transitions, managing multiple departments through organizational change, and maintaining high quality standards across global suppliers.
What’s the best career advice you’ve ever received?
The best career advice I ever received came from the engineering and quality leaders who mentored me early in my career. During times of company growth and restructuring, they consistently pushed me forward and encouraged me to step into new challenges. Each mentor taught me something uniquely valuable, from mastering calibration principles to understanding regulatory strategy, and those lessons collectively shaped the leadership approach I rely on today.
What advice would you give to young women entering your industry?
My advice to young women entering the industry is to stay curious, ask questions, and never be intimidated by technical or male-dominated environments. I recommend pursuing certifications early, staying organized, and maintaining confidence in your skills, even when stepping into complex regulatory or quality responsibilities. Embrace challenges as opportunities to learn and grow, and remember that your perspective and expertise are valuable.
What are the biggest challenges or opportunities in your field right now?
The biggest challenges in my field today include keeping up with evolving global regulations, ensuring supplier compliance, and maintaining consistent product quality across international sourcing operations. At the same time, I see significant opportunities in digital transformation, enhancing supplier auditing, and strengthening cross-functional processes, particularly following organizational changes such as mergers or acquisitions. These challenges and opportunities drive continuous improvement and innovation in quality and regulatory management.
What values are most important to you in your work and personal life?
The values that are most important to me in both my work and personal life are excellence, integrity, and service to others. Professionally, I take pride in achieving high standards, whether through earning my Six Sigma Black Belt and leading major process improvements, managing large-scale compliance transitions, or overseeing multiple departments while maintaining quality across global suppliers. Personally, I value family, community, and resourcefulness. I love spending time with my four-year-old grandson and have a passion for extreme couponing, which I use not just as a hobby but as a way to support friends, family, and my community by providing essential items like diapers, wipes, and household goods.