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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

  • LinkedIn

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 Miguel Reyes, ASQ CQM-OE, CQE, CQA

Quality Management & Compliance

  • LinkedIn

José M. Reyes is a fully bilingual (English-Spanish) seasoned industrial engineer and triple ASQ-Certified quality leader with over 30 years providing expertise within Quality Assurance, with a focus on Quality Systems Management, Compliance, and Quality Engineering. He is the Chair of the American Society for Quality (ASQ) Mid-Hudson Section 302.

 

​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 QMSR, 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) Senior Member & Chair Mid-Hudson Section 302

  • ASQ Certified Manager of Quality/Organizational Excellence

  • ASQ Certified Quality Engineer

  • ASQ Certified Quality Auditor

  • MDSAP Certified (TUV SUD)

  • Lean Six Sigma Green Belt (Air Academy Assoc.)

  • Lean Six Sigma Black Belt Trained (BD)

  • Train-The-Trainer

Services

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.

Writing Documents

QUALITY MANAGEMENT
& COMPLIANCE

  • Implementation of Quality Management Systems (QMS)

  • Auditing and Certification Preparedness & Execution

  • Development and Assessment of CAPAs/Complaints

  • SOP Development, Review, and Training

  • Technical Documentation Review and Translation 

  • GxP and Standards/Regulations Gap Assessments

  • Pharma and Medical Device Remediation

  • Fractional, Acting, or Contract Quality Manager Role

  • Person Responsible for Regulatory Compliance (PRRC) Role (EU MDR / IVDR)

TRAINING

  • Writing Effective Investigation Reports

  • Risk Management (including FMEAs)

  • Mistake-Proofing (Poke Yoke)

  • Internal Quality Audits

  • Supplier Quality Audits

  • Supplier Management

​​

  • Company SOPs (as part of QMS implementation)

Giving a Presentation

STRATEGIC OPERATIONAL PLANNING

& LEADERSHIP DEVELOPMENT

  • Nonprofit Strategic Planning

  • Operational Process Assessments

  • Business Outreach Strategy

  • Operational Strategy & Planning

  • Organizational Structure Assessment

  • Leadership Strategy

  • Logistics & Process Improvement

CONTACT

Contact Us

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Contact Us
Qualis Solutions LLC
Hudson Valley NY

Contact us and find out how our services can benefit your company.

jmreyes@qualis-solutions.com

alopez@qualis-solutions.com

Available to work remotely/hybrid  

 

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