Auditor-in-Training - Medical Devices - ISO

Company & Business Area Description
Auditor-in-Training - Medical Devices - ISO 13485
Nationwide, USA; based out of any home office
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 16,000 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.
Local Unit & Position Description
DNV GL's Business Assurance group is training Medical Device Quality Management Auditors to assess and certify medical device manufacturers and organizations against the ISO9001 Quality Management standard and the ISO13485 Medical Device Quality Management standard.
All new auditors will be required to attend our 1 week ISO9001 Lead Auditor certification course at its North American Business Assurance Headquarters in Houston, TX. Upon successful completion of the course, new auditors will conduct several observed and supervised audits before being classified as a Lead Auditor.
As an ISO13485 Medical Device Lead Auditor for DNV GL, you will audit organizations across the spectrum of the medical device industry, interacting with personnel at all levels of the management chain to assist them in developing and maintaining a culture of quality.
Tasks May Include
Perform 3rd party onsite ISO9001 and ISO13485 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
Position Qualifications
Bachelor's degree in Chemical, Materials, Mechanical, or Electrical Engineering plus 2 years' relevant medical device manufacturing and/or quality control work experience preferred
5 years' equivalent medical device industry work experience in lieu of degree
Preferred industry experience in active or non-active medical device manufacturing and/or quality control
Preferred experience conducting internal audits for a medical device manufacturing organization or supplier quality auditor
4 years of experience with the following products a plus: MD 105 (Contact Lenses); MD 202 (Orthopedic Implants); MD 402 (Dental Resins, Plastic Fillings, Dental Wrought Alloys, Dental Metal Bonding, Dental Bridges); MD 1103 (Hearing Devices, MDD); and/or MD 1202 (Imaging, Non-Radioactive; MDD)
Willing and able to travel up to 100% of the time, both domestic and international
Demonstrated proficiency in MS Excel and MS Word
Works well in a team environment or as a team of one
Strong written and verbal English communication skills
We conduct pre-employment drug and background screening
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:
Local employment conditions apply.
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