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Kaleem Mohammed

Kaleem Mohammed

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

San Jose, California

Results-driven individual with passion for Quality and Training having extensive global management expertise in overseeing Quality Systems and Regulatory Compliance in a regulated environment. Determined team leader with strong analytical skills and business insight, able to successfully develop complex relationships, solve difficult problems and deliver successful outcomes.

Broad working knowledge of regulations and standards including China Medical Device GMPs, MDSAP, QSR, ISO 13485 and ISO 14971. Certified ISO 13485:2016 Lead Auditor. Strong people management skills with emphasis on employee development and mentoring. A strong team player with excellent communication and interpersonal skills. Comprehensive knowledge of Quality and Business Management, Team Leadership and Development.

Core competencies: Customer Focused; QS Development, Implementation and Reporting; Regulatory Compliance; Product Life Cycle QA; MD OEM, Contract and Supplier Manufacturing QA; Risk Management; People Management; Internal and Supplier Audits and CAPA Management; Hosting NB Audits and Domestic and Foreign Regulatory Inspections; Strategy and Budget Planning; and Mergers and Acquisition Due Diligence Support

Experienced in establishing domestic and foreign OEM and Contract Manufacturing facilities in compliance to ISO and Regulatory requirements.

CERTIFICATIONS:
ISO 13485:2016 Lead Auditor (TPECS) Certification
AAMI - GMP/QS Requirements and Industry Practice
AAMI – Integrating Risk Management into the Quality System
AAMI - Design Control Requirements and Industry Practice
AAMI - Purchasing Controls and Supply Chain Management
AAMI - Process Validation Requirements and Industry Practice
Kellogg’s/RAPS Executive Development Program: Strategy & Leadership


Experience:

  • Manager QA & RA Compliance (Robert Bosch Healthcare Systems, Inc.)
  • Senior Program Manager Quality and Compliance (Varian Medical Systems)

Skills:

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