About

José M. Reyes is a seasoned Quality Assurance and Compliance leader with more than 30 years of experience helping organizations operate confidently within highly regulated environments. His career spans the medical device, pharmaceutical, biotechnology, aerospace, automotive, and advanced manufacturing industries, where he has supported both Fortune 500 companies and emerging organizations in building robust, audit-ready QMS for business growth. He is the Chair of the ASQ Mid-Hudson Section 302 in NY.

As Co-Founder and Partner of Qualis Solutions LLC, José provides consulting and training on FDA QSR, EU MDR, MDSAP, ISO 9001 / 13485 / 17025, AS9100, and GxP compliance. He is recognized for his ability to translate complex regulatory requirements into practical, scalable systems that organizations can sustain long after an engagement ends. His work includes audit readiness, remediation, supplier quality management, CAPA systems, risk management, and process and design validation development, execution, and reviews.

What differentiates José as a trainer is his deeply practical, experience-based approach. Having led and supported FDA inspections, ISO and EU MDR audits, global remediation efforts, and high-risk investigations, he teaches from real-world application rather than theory. His training philosophy emphasizes understanding the “why” behind requirements, empowering teams to make sound, risk-based decisions and embed quality by design across their operations.

José holds a B.S. in Industrial Engineering (cum laude) and multiple professional certifications, including ASQ Certified Manager of Quality/Organizational Excellence, Certified Quality Engineer, Certified Quality Auditor, MDSAP certification, Lean Six Sigma credentials (GB, BB Trained), and Kepner-Tregoe (RCA) certification. Fully bilingual in English and Spanish, he brings clarity, credibility, and cultural fluency to every engagement, helping organizations build lasting quality capability and trust.

We provide remote and hybrid quality system consulting services in the New York Tri-State area, Pennsylvania, and Puerto Rico, with the flexibility to serve beyond these regions.  We help you ensure compliance within your organization by providing expertise in Quality Systems Management, Regulatory Compliance, and Quality Engineering, as well as streamlining and bootsting the efficiency of your operations.