
Qualis Solutions LLC | Jose M. Reyes (Partner) | jreyesmarquez@qualis-solutions.com
Categories
Business & Professional Business Services Engineers Healthcare Manufacturing
About
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.
Additional Info
José M. Reyes is a fully bilingual (English/Spanish) seasoned industrial engineer, Partner at Qualis Solutions, and an ASQ-certified quality leader, providing expertise and a proven track record in Quality Assurance with a focus on Quality Systems Management, Compliance, and Quality Engineering within the pharmaceutical, medical device, aerospace, and automotive industries. Some areas covered are compliance per ISO 9001/13485, FDA QSR, MDSAP, EU MDR, Change control, CAPA, complaints, health hazard assessments, Quality Auditing (Supplier and Internal), Quality Engineering (risk assessments, root cause analysis), Products transfers & New product introductions, Continuous Improvement mostly via Lean Six-Sigma tools, Process/design validation and Design Controls on existing and new products, and Supplier Management.
Aixa G. Lopez, P.E., is a fully bilingual (English/Spanish) licensed industrial engineer and the Managing Partner at Qualis Solutions. With over 30 years of experience in engineering, operations, and strategic planning, she directs the organization’s strategic initiatives, process enhancements, and operational management, while helping clients enhance their organizational effectiveness and efficiency. Aixa is renowned in the industry for enhancing organizational performance through strong leadership and aligning business processes to drive cost savings and growth. Among Aixa's accolades, she has been named as 2020 NJBiz Women in Business, 2024 Latina Influencer, 2025 ROI-NJ Women in Business Influencer, and 2025 Mujer Destacada.