uantum
uality
group, llc
Next level compliance!
About Us
We are a life sciences consulting service provider in quality and compliance related operations. Our primary focus is to provide top-notch services to medical devices, pharmaceutical, and biotechnology manufacturers in the area of quality compliance.
Our team of experts brings years of experience and knowledge to ensure that our clients meet all regulatory requirements and achieve the highest level of quality in their products. Our services include everything from quality system design and implementation to compliance assessments and gap analysis.
We are committed to providing customized solutions to our clients that are tailored to their specific needs, goals, and objectives. Our goal is to help our clients navigate the complex landscape of quality compliance and achieve long-term success in their industry.
OUR ADVANTAGE
years of experience
Our team of consultants has an impressive collective experience in the field of quality compliance consulting, which allows us to provide our clients with the highest level of expertise and knowledge in the industry.
recognized for our expertise
Our expertise in quality compliance consulting has been recognized by industry associations and regulatory bodies, as well as through long-standing partnerships with leading manufacturers.
from start to finish
What sets our quality compliance consulting services apart is our unwavering commitment to providing personalized solutions that are tailored to the unique needs and challenges of each client, ensuring the highest level of compliance and quality in their products.
OUR Services
CONSULTING
- Quality Compliance Assessments
- Internal Audits & Third Party Audits
- Inspection Management
- Audit Response & Corrective Action Plan
- Quality Metrics Determination
- QS Development & Documentation
- Technical Writing
- Regulatory Intelligence: Data gathering and analysis to monitor of regulatory climate
TRAININGS
- Training customized courses
- Curriculum Development
- Quality Academy
Our
Expertise
Our team is has demonstrated considerable knowledge of and success in performing compliance-related projects through the implementation of remediation and continuous improvement activities.
- Certified Lead Auditor for ISO 13485:13485
- Certified Lead Auditor for ISO 9001:2015
- ASQ Certified Quality Auditor (CQA)
- Medical Devices Auditor (CMDA)
- Quality Engineer (CQE)
- Medical Devices Single Audit Program
- EU Medical Devices Regulation
- Project Management Professional
- Certified Professional Inspector
- Others
Contact us
Today
If you would like to learn more about our services and how we can support your organization's quality compliance efforts, please don't hesitate to get in touch. We look forward to the opportunity to work with you and help your organization achieve its quality goals
Lismarie Alamo
PRESIDENT
689-242-2560 office
689-242-2084 office
