Mahmud Ahmed

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, vendor assessments, risk management, and leading complex investigations to drive continuous improvement and ensure regulatory compliance. Passionate about empowering teams and fostering a culture of quality excellence.

### **Additional information**

- **Type:** independent
- **Years of experience:** 13
- **Ex-Big MedTech:** Yes
- **Regions served:** US
- **Client types:** startup, sme, large_medtech
- **Location:** United States (CT)
- **Availability:** available_now
- **Certifications:** Quality Management System Lead Auditor, Certified Quality Auditor, Lead Auditor ISO 9001:2015 Certified

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### **Cruxi analysis**

- **Strength summary:** 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.
- **Unique value:** Mahmud Ahmed's unique value lies in his comprehensive, hands-on experience in establishing and auditing critical quality systems within the medtech sector, backed by a strong foundation in advanced quality methodologies. His proven track record with key ISO standards and risk management frameworks, combined with his background from large medtech environments, offers a distinct advantage for companies seeking practical, efficient, and compliant QMS solutions.
- **Ideal projects:** This consultant is ideally suited for medtech companies, ranging from startups to large enterprises, seeking to establish or enhance their Quality Management Systems. He excels in projects requiring comprehensive ISO 13485 and ISO 9001 implementation, particularly for general hospital device types. Companies preparing for Q-Sub submissions or requiring expert FDA mock audits will find his expertise invaluable. His proficiency in risk management (ISO 14971) and his strong background in Lean and Six Sigma methodologies make him a perfect fit for organizations prioritizing continuous improvement, robust CAPA processes, and efficient regulatory pathways. Engaging Mahmud early in the product development lifecycle or during system remediation efforts will significantly de-risk the path to market.
- **Last analyzed:** Mon Jan 05 2026 15:37:02 GMT-0500 (Eastern Standard Time)

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### **Qualifications & scope**

- **Submission types:** qms
- **Specialties:** general-hospital
- **Regulatory pathways:** q_sub

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• This consultant is ideally suited for medtech companies, ranging from startups to large enterprises, seeking to establish or enhance their Quality Management Systems. He excels in projects requiring comprehensive ISO 13485 and ISO 9001 implementation, particularly for general hospital device types. Companies preparing for Q-Sub submissions or requiring expert FDA mock audits will find his expertis

HQ: United States

Languages: English

Status: claimed

Jurisdictions: US