Independent Contractor
Highly accomplished Quality Manager and Lead Auditor with over a decade of experience in establishing, implementing, and optimizing Quality Management Systems (QMS) for diverse organizations. Proven expertise in ISO 9001:2015, ISO 13485:2016, and ISO 14971:2012, with a strong command of Lean Manufacturing, Six Sigma, and FMEA methodologies. Adept at conducting third-party certification audits, ven...
Experience: 13+ years
Mahmud Ahmed provides regulatory consulting services to clients in:
Possesses a Bachelor’s degree in Physics/EE from the University of Hartford, providing a strong foundation in technical principles essential for understanding complex medical devices and regulatory requirements. This educational background equips them with the analytical and problem-solving skills necessary to navigate the intricacies of medical technology and its regulatory landscape. Their scientific and engineering education is a valuable asset for medtech companies seeking expertise in product development and quality assurance. Master of Science in Quality Assurance (MSQA) from California State University, Dominguez Hills, California
A Senior Member of the American Society for Quality (ASQ) and holds a RAB/QSA affiliation, demonstrating a strong commitment to professional development and industry best practices. These affiliations highlight a dedication to maintaining high standards in quality management and regulatory affairs within the medtech sector.
A highly experienced Quality Manager and Lead Auditor with a robust history of managing and optimizing Quality Management Systems (QMS) across various organizations. Proven success in conducting third-party certification audits, vendor assessments, and leading remediation projects. Demonstrated ability to serve as a Quality Systems subject matter expert, driving continuous improvement through root cause investigations and CAPA implementation. Their extensive background includes strategic planning for Quality, Training, and Process Documentation programs, consistently aligning with business objectives and ensuring compliance.
Highly accomplished Quality Manager and Lead Auditor with over a decade of experience in establishing, implementing, and optimizing Quality Management Systems (QMS) for diverse organizations. Proven expertise in ISO 9001:2015, ISO 13485:2016, and ISO 14971:2012, with a strong command of Lean Manufac...
Mahmud Ahmed brings a robust 13 years of specialized experience as a Quality Manager and Lead Auditor, making him an exceptionally valuable asset for medtech companies navigating complex regulatory landscapes. His deep expertise in ISO 13485:2016, ISO 9001:2015, and ISO 14971:2012, coupled with a strong command of Lean, Six Sigma, and FMEA, equips him to build, implement, and optimize robust Quality Management Systems essential for FDA compliance. His proven ability to conduct third-party certification audits and lead complex investigations ensures that medtech firms can achieve and maintain the highest standards of quality and regulatory adherence. Mahmud's background as an ex-big medtech professional further sharpens his practical understanding of industry challenges, enabling him to provide strategic and actionable guidance tailored to the specific needs of startups, SMEs, and large medical device organizations.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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