Identifying Challenges Implementing Solutions

We help you identify challenges, devise strategies, and streamline time-consuming tasks so your team can concentrate on daily business operations.

Meet the Team

Expert solutions for complex organizational challenges. Tailored to your unique business and compliance needs.

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Aixa G. López, P. E.

Strategic & Operational Planning

Aixa G. Lopez, P.E., is a licensed industrial engineer and the managing member 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.

As a consultant, Aixa helps clients enhance their organizational effectiveness and efficiency.

Her achievements include being named:

Aixa is renowned in the industry for enhancing organizational performance through strong leadership and aligning business processes to drive cost savings and growth.

Additionally, she serves on the board of PAYE, a non-profit organization dedicated to improving educational access in Puerto Rico.

Aixa thrives in high-pressure environments, adeptly prioritizing and managing multiple tasks while consistently exceeding goals. She is bilingual in English and Spanish. Key skills include Strategic Planning and Operations Management, team leadership, and process improvement.

ASSOCIATIONS:

Member of the Puerto Rico Professional College of Engineer and Land Surveyors

José M. Reyes, ASQ CQM-OE, CQE, CQA

Quality Management & Compliance

José M. Reyes is a fully bilingual (English-Spanish) seasoned industrial engineer and triple ASQ-Certified quality leader providing expertise within Quality Assurance, with a focus on Quality Systems Management, Compliance, and Quality Engineering.

His proven track record in the pharma, medical device, aerospace, and automotive industries includes, but is not limited to:

Quality Management Systems: ISO 9001/13485, FDA QSR, MDSAP, EU MDR compliance,
Change control, CAPA, complaints, health hazard assessment
Quality Auditing: Supplier and Internal systems
Quality Engineering: risk assessments, root cause analysis
Products transfers & New product introductions
Continuous Improvement: Lean Six-Sigma tools
Process/design validation & Design Controls: On existing and new products
Supplier Management

ASSOCIATIONS & CERTIFICATIONS:

American Society for Quality (ASQ)
ASQ Certified Manager of Quality/Organizational Excellence
ASQ Certified Quality Engineer
ASQ Certified Quality Auditor
MDSAP Certified
Lean Six Sigma Green Belt
Lean Six Sigma Black Belt Trained
Train-The-Trainer

Services

Providing remote and hybrid 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, streamline your operations, and boost efficiency.