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ISO 13485 Lead Auditor

DNV GL Katy, TX Full-Time
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Local Unit & Position Description

DNV GL - Business Assurance North America is seeking an ISO 13485 Lead Auditor. The ISO 13485 Lead Auditor partners with clients in the Medical Device industry to improve the quality and safety of their business performance through the application of internationally recognized standards.DNV GL Business Assurance North America is a leading provider of accredited management systems and product compliance certification.

We offer a broad portfolio of services across a variety of disciplines and industries. Our auditors are generally based remotely allowing them to work independently as they travel to client sites while receiving a full complement of administrative support from our central office in Katy, TX. 

Tasks May Include

  • On-site and off-site technical assessments of Medical Devices against Medical Device Directive
  • Perform 3rd party on-site ISO 13485 (Medical Device) audits for North America customers
  • 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


  • Must have a Bachelors Degree or higher in biology or microbiology; chemistry or biochemistry, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics or other related fields
  • Must have a minimum of 4 years experience in the medical devices industry
  • Must be currently approved as a competent Lead Auditor for ISO 13485 by a Certification Body – Third Party certification Lead Auditor? (NO Exceptions)  
  • Must have a minimum of 1 year of expedience as ISO 13485 Third Party certification Lead Auditor? 
  • Must Have a working knowledge of ISO 13485 Codes: MD0100, MD0105, MD0200, MD0203
  • Must have a working knowledge of ISO 14971, medical device risk management 
  • Must have successfully completed training and competence evaluation within Medical Device Directive and ISO 13485
  • Must be willing and able to travel to client sites up to 100% of the time
  • Must have demonstrated excellent customer service skills
  • Must possess a valid driver’s license and be able to rent and drive a car and travel on public conveyances when required
  • Must have the ability to work independently and in teams
  • Must be analytical, empathetic and able to communicate effectively, respond calmly and make decisions
  • Must be able to walk and stand for up to 4 hours at a time and maneuver throughout multiple levels of client sites either by stairs or elevator?
  • Must be able to lift and carry up to 10 pounds in addition to transporting one’s own luggage for multiple-day travel and push, pull reach, bend, twist, stoop and kneel with that which is lifted, carried or transported
  • We conduct pre-employment background check and drug screen

Opportunities Beyond Business
Our mission is to safeguard life, property and the environment. By joining us, you will work towards our meaningful vision: to make a global impact for a safe and sustainable future. DNV GL offers a congenial working environment, competitive salaries, and an exceptional benefits package.

DNV GL is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to race, color, religion, age, sex, national origin, disability or protected veteran status.  For more information about your rights under the law, see:[ Link removed ] - Click here to apply to ISO 13485 Lead Auditor  

Local employment conditions apply. 

Please visit our website at [ Link removed ] - Click here to apply to ISO 13485 Lead Auditor

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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ISO 13485 Lead Auditor
Estimated Salary: $75K
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Job ID: 2020-13685


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