IVDR Experienced Auditor

All locations
  • Houston, TX, United States
  • United States
Business:
Supply Chain & Product Assurance
Position type:
Full Time
Contract type:
Permanent Employee
Job ID:
4826
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Overview

About us

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About the role

We are seeking an experienced and highly motivated IVDR Auditor to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. This position can be remote from anywhere in the Continental U.S with travel to customer sites up to 75% of the time

What You'll Do:

  • Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits.
  • Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
  • If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements.
  • Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

What we offer
  • Generous paid time off (vacation, sick days, company holidays, personal days)
  • Multiple Medical and Dental benefit plans to choose from, Vision benefits
  • Spending accounts – FSA, Dependent Care, Commuter Benefits, company-seeded HSA
  • Employer-paid, therapist-led, virtual care services through Talkspace
  • 401(k) with company match
  • Company provided life insurance, short-term, and long-term disability benefits
  • Education reimbursement program
  • Flexible work schedule with hybrid/remote opportunities
  • Charitable Matched Giving and Volunteer Rewards through our Impact Program
  • Volunteer time off (VTO) paid by the company 
  • Career advancement opportunities

**Benefits may vary based on position, tenure, location, and employee election

DNV is a proud equal opportunity employer committed to building an inclusive and diverse workforce. All employment is decided on the basis of qualifications, merit or business need, without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

DNV is committed to ensuring equal employment opportunity, including providing reasonable accommodations to individuals with a disability. US applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may contact the North America Recruitment department (hrrecruitment.northamerica@dnv.com). Information received relating to accommodations will be addressed confidentially.

For California, Washington, New York, Washington, D.C., Illinois, and Maryland: “DNV provides a reasonable range of compensation for this role. The actual compensation is influenced by a wide array of factors, including but not limited to skill set, level of experience, and specific location. For the states of California, Washington, New York, Washington, D.C., Illinois, and Maryland only, the starting pay range for this role is $95000- $175000.

Deadline to Apply: Aug. 22, 2025

About you

What Is Required:

Assessors and Auditors shall have a technical college degree in a relevant product or medical area, as described below.
In-Vitro Diagnostic devices:

  • Biology or Microbiology
  • Chemistry or Biochemistry
  • Human Physiology
  • Medical Technology or Biotechnology
  • Medicine, Veterinary Medicine
  • Biomedical science - e.g. hematology, virology, molecular diagnostics
  • Nursing
  • Pharmacy, Pharmacology, Toxicology
  • Physiology

In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit or Assessment, and/or experience as an assessor or auditor in a notified body. Specifically:

Auditor - Practical experience in the quality management system and specific production process/technologies for the IVD medical devices.

Assessor - Practical experience in conducting and/or assessing performance evaluation data or related scientific aspects with in-vitro diagnostic medical devices in one or more of the following areas Microbiology, Immunology, Genetic testing/Cancer Biology and Molecular Biology.

A PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing.


In addition to the above, knowledge of the following would be preferred:
  • An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
  • Work experience in positions with significant QA Regulatory or management systems responsibility.
  • Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices.
  • Experience with Risk Management EN ISO 14971.
  • Medical device experience from auditing/work.
  • Experience auditing against recognized standards.
  • Experience of working under own initiative and in planning and prioritizing workloads.
  • Should have a flair for technical writing, essential for exhaustive report writing.
  • We conduct a pre-employment background check and drug screen.

*Immigration-related employment benefits, for example visa sponsorship, are not available for this position*

Benefits

Profit Share

You’ll be part of our global profit share scheme that means we all share in our success as a business. If we profit, so do you. This will be part of our Total Compensation approach each year and depends on our year-end results.

Personal Development

You’ll have a lot of opportunities to learn and grow. Whether it’s building your network, having resources to plan and realise your career goals or enjoying genuine freedom to satisfy your curiosity, we’ll make sure you’re always growing and developing.

Purpose-led organization

You become part of a world-leading company where we know and live our purpose; to safeguard life, property, and the environment, with the opportunity to tackle global change through your work.

401(k)

DNV provides the option for eligible employees to enroll in our professional managed 401(k) plan. We’ll match up to a percentage of employee elected investment, which will become fully vested after a few years.

Healthcare and more

You’ll have multiple medical plans to choose from including Dental, Vision, RX plans, AD&D, Critical Illness, ST/LT Disability, Paid Parental Leave, Virtual TalkSpace Therapy.

Additional benefits

ID theft protection, generous PTO accrual, company paid holidays, discounted pet insurance, charitable donation matching, additional vacation hours purchase plan, commuter benefits, Employee Assistance Program (EAP), tuition reimbursement.

Diversity, Equity and Inclusion

At DNV, our commitment to Diversity, Equity, and Inclusion is not only an ethical choice, but also a business decision.

Diversity, fairness, and a sense of belonging are a source of strength for our people, our business, and our customers, and help us to deliver on our purpose, vision, and values.

Learn more

Working here

Since 1864 we’ve been dedicated to safeguarding life, property and the environment. Today we remain at the forefront of new technologies and techniques to help our customers transform for a more sustainable future.

At DNV you can expect to deliver career and industry defining work. You’ll be given the time to build your network, the resources to support your development, and the freedom to satisfy your curiosity and desire to learn.

Learn more

Application Process

FAQs

Welcome to our Frequently Asked Questions page. We’ve put together answers to the questions we’re asked most often to help you find the information you need quickly and easily. Whether you're curious about our recruitment process, benefits or career growth and development, you should find the information below.

How can I find job openings that fit my skills and interests?

Explore our official job search page where you can use filters such as job type, location, and department to find roles that best match your qualifications and career aspirations.

What’s your application process like?

You can apply directly through our careers page by submitting your CV and any other documents we require (i.e. university diplomas/transcripts; visas; previous employment reference letters). Make sure your application is fully completed, and you tailor it to the specific job listing. 

Is your recruitment process designed to be inclusive and accessible?

Yes, it is. We're an equal opportunities employer and welcome applications from all candidates. We’re happy to support your need for any adjustments during the application and hiring process. Share the details of what you need within your application.

What types of interviews might I undergo?

Depending on your role, our interview process may include initial phone screenings, video conferences, and in-person interviews, focusing on both your technical abilities and our shared values. You can ask your recruiter specifically about the interview process for your role. 

How long does the hiring process typically take from application to decision?

The timeline can vary but we make every effort to reply to each candidate as soon as possible and keep everyone up-to-date with where they are in the recruitment process.

How do I know if a recruitment contact is legitimately from your company?

Official communication will come from our verified company email addresses. Carefully check any suspicious looking emails and if you have any doubts, don’t engage.

Are there any fees involved in your recruitment process?

No, we do not charge any fees at any stage of our recruitment process. All applications and interviews are free of charge, we will never ask you to pay any fees or make any payments – please be wary of any requests for payment as these are likely scams.

What should I do if I suspect a job scam?

If you encounter suspicious job postings or recruitment practices, do not provide personal information and contact your recruiter as soon as possible. We take these matters seriously. We will never ask you to pay any fees or make any payments part of our recruitment process.

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Disclaimer

Please beware of recruitment scams that pretend to be from DNV or its employees. We will never ask you to pay any fees or make any payments as part of our recruitment process.