Mahmud Ahmed
Expert QMS Lead Auditor & Quality Manager | ISO 13485, ISO 9001, ISO 14971, Lean, Six Sigma
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.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Years Experience:
13
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Accepting New Clients:
No
