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Identifying Challenges                            Implementing Solutions

We assist you in identifying challenges, strategizing, and streamlining time-consuming tasks, allowing your staff to focus on daily business operations.

Discussing the Numbers

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Qualis-Solutions, LLC provides expert solutions for complex organizational challenges. Our experienced team develops tailored solutions aligned to your unique business needs. Partner with us for quality service that exceeds expectations.

About Aixa
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Aixa G. Lopez, P.E.

Aixa G. Lopez, P. E., is a licensed professional industrial engineer, and

President at Qualis Solutions.

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 With over thirty years of engineering, operational, and strategic planning experience, she oversees organizations' strategic planning, process improvement, and

operational management.  As a consultant, she helps clients with organizational effectiveness and efficiency. 

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Recognized as one of the selected 2020 NJBiz Women in Business, 2022 ROI-NJ's People of Color Influencers, and 2024 ROI-NJ's Women in Business Influencers, Aixa is well-known in the industry for improving organizational effectiveness and efficiency through leadership and aligning business processes to achieve cost savings

and revenue growth.

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Aixa also serves as a board member at PAYE, a non-profit organization that improves educational access in Puerto Rico.

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Aixa works well in high-pressure situations, and efficiently prioritizes and handles

multiple tasks while effectively exceeding goals. 

Bilingual in English and Spanish.

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Key skills:

Strategic Planning and Operations Management,

Team Leadership & Process Improvement

About Jose
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 Jose Reyes-Marquez, CQM-OE, CQE, CQA

Jose Reyes-Marquez is a fully-bilingual (English-Spanish) seasoned engineer, and ASQ Certified quality leader providing expertise within

Quality Assurance, with a focus on Quality Systems Management, Compliance, and Quality Engineering.

 

His proven track record includes, but is not limited to:

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  • Quality Systems: ISO 9001/QSR/ISO 13485 compliance, change control, CAPA

  • Quality Engineering tools: risk assessments, statistical analysis, root cause analysis

  • Continuous Improvement: Lean Six-sigma tools

  • Process/design validation, on existing and new products

  • Supplier (external) and internal Quality Systems auditing

 

CERTIFICATIONS

  • ASQ Certified Manager of Quality/Organizational Excellence

  • ASQ Certified Quality Engineer

  • ASQ Certified Quality Auditor

  • Lean Six Sigma Green Belt

  • Lean Six Sigma Black Belt Training

 

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Services

Services

We understand that your team may need additional support to identify solutions, review, assess, and create systems that can help streamline processes and improve efficiency. Our effective remote support services are available to businesses located in states such as New York, New Jersey, and Puerto Rico. You can count on us to help your staff with their day-to-day tasks so they can focus on what they do best.

STRATEGIC OPERATIONAL PLANNING

& LEADERSHIP DEVELOPMENT

  • Nonprofit Strategic Planning

  • Government Operational Assessments

  • Business Outreach Strategy

  • Operational Strategy & Planning

  • Organizational Structure Assessment

  • Leadership Strategy

  • Logistics & Process Improvement

Writing Documents

QUALITY MANAGEMENT & COMPLIANCE

  • Evaluation of Quality Management Systems (QMS)

  • Assessment and Implementation of CAPA Systems

  • SOP Development and Reviews

  • Technical Documentation Review and Translation 

  • GMP and Standards Gap Assessments

  • Pharma and Medical Device Remediation

TRAINING

  • Writing Effective Investigation Reports

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  • FMEA - Managing Risk

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  • Mistake-Proofing

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Giving a Presentation
Casual Business Meeting

CONTINUOUS IMPROVEMENT

  • Lean Six Sigma Tools Application

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  • ISO 9001 Certification Support

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  • Rapid CI Tools: Kaizen, Poka-yoke, 5S

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  • PDCA / DMAIC / DMADV

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Contact Us

Contact us and find how our services can benefit your company.
Fill out the form and we will get back to you.

973.735.8312  |   Newburgh, NY  (covering NY, NJ & Puerto Rico)

Available to work remotely  |  alopez@qualis-solutions.com

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