Lead Auditor / MDD and MDR Assessor

DNV GL
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  • Location VN-Ho Chi Minh City
    Requisition ID
    Position Type

Local Unit & Position Description

The Lead Auditor/MDR &MDD Assessor is responsible for performing 3rd party onsite ISO 13485 (Medical Device) audits and MDD/MDR Technical file assessment as well as 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

  • Perform 3rd party onsite ISO 13485 (Medical Device) audits and MDD/MDR Technical file assessment for Vietnam, 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, Biotechnology, Biomedical Engineering, 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

DNV GL is a global quality assurance and risk management company. Driven by our purpose of safeguarding life, property and the environment, we enable our customers to advance the safety and sustainability of their business. We provide classification, technical assurance, software and independent expert advisory services to the maritime, oil & gas, power and renewables industries. We also provide certification, supply chain and data management services to customers across a wide range of industries.

 

Combining technical, digital and operational expertise, risk methodology and in-depth industry knowledge, we empower our customersโ€™ 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. With origins stretching back to 1864 and operations in more than 100 countries, our experts are dedicated to helping customers make the world safer, smarter and greener.

 

DNV GL is one of the worldโ€™s leading certification bodies. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries.

Equal Opportunity Statement

DNV GL is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

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Vietnam