• ISO 13485 Lead Auditor/MDD Assessor

    Location MY-Kuala Lumpur | SG-Singapore
    Requisition ID
    2018-11247
    Business Area
    Business Assurance
    Category/Discipline
    Auditing
    Location Details
    Kuala Lumpur or Singapore
    Position Type
    Permanent employment
    Close Date (dd/mm/yyyy)
    22/9/2017
  • Local Unit & Position Description

    DNV GL - Business Assurance Singapore & Malaysia are seeking an ISO 13485 Lead Auditor/MDD Assessor.

     

    The ISO 13485 Lead Auditor and MDD Assessor is responsible for achieving growth in sales through new business development, leading the delivery of projects, and ensuring service excellence for clients. This position helps clients to improve the quality and safety of their business performance through the application of internationally recognized standards.

     

    Tasks May Include 

     

    • Perform 3rd party onsite ISO 13485 (Medical Device) audits and MDD Technical file assessment for Singapore, Malaysia and other countries in South East Asia.
    • Schedule and plan audit activity with customers.
    • Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system.
    • Document and report audit activities and results.
    • Provide timely and accurate reviews of customer corrective action and closure.
    • Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed.

    Position Qualifications

    • Academic qualifications such as Bachelor's Degree in Biology, Chemistry, Electrical/Electronics, Medicine or other related fields;
    • Must have a minimum of 4 years experience in the medical devices industry;
    • Must have an ISO 13485 Auditor Certification;
    • Must Have a working knowledge of ISO 13485 Codes for Active and/or Non-Active;
    • Must have a working knowledge of ISO 14971, medical device risk management; 
    • Must have successfully completed training within Medical Device Directive and ISO 13485;
    • Must have the ability to work independently and in teams;
    • Proven project and/or team leader, delivering service excellence;
    • Excellent interpersonal skills, with excellent customer service skills;
    • Ability to speak very well in English and local language, both written and verbal;
    • Ability to work in an international team, delivering and leading teams to produce high quality deliverables on time and in budget;
    • Ability to lead multiple projects in parallel, often with conflicting demands and timelines;
    • Willingness to travel and work around SEA and other locations.

    Company & Business Area Description

    Driven by our purpose of safeguarding life, property and the environment, DNV GL enables organisations to advance the safety and sustainability of their business. We provide classification and technical assurance along with software and independent expert advisory services to the maritime, oil & gas and energy industries. We also provide certification services to customers across a wide range of industries.

     

    Combining leading technical and operational expertise, risk methodology and in-depth industry knowledge, DNV GL empowers our customers’ decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.

     

    Originated in 1864, DNV GL operates globally in more than 100 countries with our 15,000 professionals dedicated to helping our customers make the world safer, smarter and greener.

     

    As a world-leading certification body, we work with companies to assure the performance of their organisations, products, people, facilities and supply chains through certification, verification, assessment and training.  As part of the larger DNV GL Group, our 2,000 Business Assurance employees worldwide help our customers build sustainable business performance and create stakeholder trust.  We promise to be focused on your future.

     

    With more than 70,000 certificates issued worldwide, our name evokes a strong commitment to safety, quality, and concern for the environment. For years, we have been the preferred certification partner for many Fortune 500 companies, as well as for medium and smaller businesses.  

     

    With our extensive local presence, consolidated global experience across industries and acknowledged technical competence, we are an ideal partner for companies in all sectors. We partner with our customers to help them create value while meeting the world’s economic, social and environmental needs.

     

    Through our certification, verification, assessment and training services, we assure the performance of our customers’ organisations, products, people, facilities, and supply chains.  Working with companies in most industries, and some of the world’s leading brands, in practice, we are virtually everywhere.

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