Rizwan Ebad

AGM - Quality Assurance at MEDICO ELECTRODES INTERNATIONAL LIMITED
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Contact Information
us****@****om
(386) 825-5501
Location
Noida, Uttar Pradesh, India, IN

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Rizwan was one of the most dedicated professionals I have come across at FCRL. I have always admired his sincerity, time management skills and deep understanding of the subject. He proficiently executed the role of an efficient auditor: lot of work and little talk. We attended a business conference together where I came to know the lighter side of him- an amazing mimic with a pleasing sense of humor. He’s soft spoken and friendly, not to miss his good looks and great dressing sense- in short, a wonderful person to work with. Highly recommended.

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Credentials

  • Awareness on EN ISO 14971:2012-Medical Devices Risk Management Requirements
    DNV GL
  • Internal Auditor Certification - ISO 13485-Quality Management Systems - Requirements for Regulatory Purposes-Medical Devices
    DNV GL

Experience

    • India
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • AGM - Quality Assurance
      • Apr 2022 - Present

    • Senior Manager-Quality Assurance
      • Apr 2018 - Apr 2022

    • Manager Quality Assurance
      • Jan 2016 - Apr 2018

    • France
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Head - Quality Assurance & Quality Control
      • Feb 2014 - Jan 2016

    • Quality Head & Management Representative
      • Jan 2015 - 2016

      Heading and Managing performance of site’s comprehensive Quality Assurance, Quality Control and Process Controls in achieving established customer requirements and all applicable regulatory requirements. Ensuring that processes needed for the quality management system are established, implemented and maintained. Reporting to top management on the performance of the quality management system and any need for improvement. Ensuring the promotion of awareness of regulatory and customer… Show more Heading and Managing performance of site’s comprehensive Quality Assurance, Quality Control and Process Controls in achieving established customer requirements and all applicable regulatory requirements. Ensuring that processes needed for the quality management system are established, implemented and maintained. Reporting to top management on the performance of the quality management system and any need for improvement. Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization. Liaison with external parties on matters relating to the quality management system. Ensuring compliance with established Corporate Quality System (CQA) procedures. Developing, implementing & maintaining quality assurance policies, process controls and ensuring that application,performance,intended use and quality of implantable devices strictly conform to company's quality objectives, international standards (ISO) primarily ISO 13485 and 9001 along with CE Mark ( Conformité Européenne ) as per Medical Device Directives 93/42/EEC with amendments by 2007/47/EC,Canadian Medical Devices Regulations (CMDR-SOR/82-282), WHO-GMP, governmental regulatory standards (Schedule M & M III-Rule 76), related guidelines to ensure customer safety by evaluating PMCF Studies & interpreting clinical investigations. Handling Regulatory Affairs with new product registrations & renewals,technical documentation involved in tender applications in European Union,Australia,Canada,Far East, Asian,Mediterranean & African Countries. Responsible for regulatory compliance,Clients' Feedbacks,Complaint resolutions, Product Recalls & Supplier quality. Responsible for Risk Analysis of MDD Class III & Class IIb implantable medical devices and mitigating high risk during a product life cycle. Maintaining quality through internal and external inspection of each raw material procured & finished deliverable, In-Process operations and overall workflow.

    • Senior Research Officer-1 (QA Auditor)-Bioanalytical & Clinical Ops)
      • Jul 2007 - Feb 2014

    • Quality Inspector & Analyst
      • 2005 - 2007

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