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    Kaleem Mohammed

    QMS - QA - Regulatory Compliance - PLC QA - Medical Device OEM & Contract MFG. - Supplier Quality - Audits & Inspections

    Kaleem Mohammed is a results-driven individual with a passion for Quality and Training, bringing extensive global management expertise in overseeing Quality Systems and Regulatory Compliance in regulated environments.

    With a deep understanding of regulations and standards like ISO 13485, ISO 14971, China Medical Device GMPs, and MDSAP, Kaleem holds the Certified ISO 13485:2016 Lead Auditor certification and excels at people management with a focus on employee development and mentoring.

    His core competencies include Customer Focus, Regulatory Compliance, Risk Management, Team Leadership, and Strategy Planning, along with experience in establishing OEM and Contract Manufacturing facilities both domestically and internationally.

    Education-wise, Kaleem has a background in Computer Electronics Technology from San Jose State University, Geology, Physics, and Chemistry from Osmania University, and certifications from BSI and AAMI in ISO 13485:2016 Lead Auditor, GMP/QS Requirements, and Integrating Risk Management into the Quality System.

    Currently serving as a Senior Program Manager Quality and Compliance at Varian Medical Systems, Kaleem previously held the position of Manager QA & RA Compliance at Robert Bosch Healthcare Systems, Inc.

    He brings a wealth of experience in hosting audits, managing CAPAs, overseeing quality assurance throughout the product life cycle, and contributing to mergers and acquisition due diligence support.

    Kaleem Mohammed
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    Location

    San Jose, California