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.
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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.
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
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
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Quality Engineering tools: risk assessments, statistical analysis, root cause analysis
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Continuous Improvement: Lean Six-sigma tools
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Process/design validation, on existing and new products
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Supplier (external) and internal Quality Systems auditing
CERTIFICATIONS
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ASQ Certified Manager of Quality/Organizational Excellence
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ASQ Certified Quality Engineer
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ASQ Certified Quality Auditor
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Lean Six Sigma Green Belt
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Lean Six Sigma Black Belt Training
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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
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Nonprofit Strategic Planning
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Government Operational Assessments
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Business Outreach Strategy
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Operational Strategy & Planning
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Organizational Structure Assessment
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Leadership Strategy
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Logistics & Process Improvement
QUALITY MANAGEMENT & COMPLIANCE
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Evaluation of Quality Management Systems (QMS)
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Assessment and Implementation of CAPA Systems
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SOP Development and Reviews
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Technical Documentation Review and Translation
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GMP and Standards Gap Assessments
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Pharma and Medical Device Remediation
TRAINING
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Writing Effective Investigation Reports
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FMEA - Managing Risk
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Mistake-Proofing
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CONTINUOUS IMPROVEMENT
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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
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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