Senior Lead Auditor - Medical Devices

Location:
Houston, TX, United States
Business:
Supply Chain & Product Assurance
Position type:
Full Time
Contract type:
Permanent Employee
Job ID:
5773
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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

DNV Business Assurance USA, Inc. seeks a Senior Lead Auditor - Medical Devices to work for our office in Houston, TX.

Job Duties:

  • Efficiently and competently implement ISO13485 & MDR auditing and assessment work for clients based on the CE Directives, International standards, other applicable Regulatory Systems and DNV's accredited certification program.
  • 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.
  • Maintain appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed.
  • Responsible for achieving KPI-targets.
  • Ensure work is executed with absolute independence, and integrity at all times.
  • Contribute to the ongoing improvement of operational efficiency and effectiveness by means of the identification and pursuit with regards to audit processes and handling of information within the team and unit, facilitating the rendering of service also to other functions within the organization as required.
  • Organize and deliver projects, i.e., assessment, gap analysis, training and customer workshops, etc.
  • Maintain assessor/auditor registration with DNV and other relevant authorities to work as a Senior Auditor at DNV.
  • This position requires 85% domestic, 5% international travel to client sites.
  • Role is hybrid allowing periodic work from within a reasonable commuting distance of the Houston, TX office.

What we offer

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 offers a congenial working environment, competitive salaries, and an exceptional benefits package.

Local employment conditions apply.

Please visit our website at www.dnv.com

Company & Business Area Description

DNV is one of the world’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 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! For more information about your rights under the law, see: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

About you

Main Requirements:

Bachelor’s degree in Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical engineering or Bioengineering, Human Physiology, Medicine or Veterinary Medicine, Pharmacy, Physics or Biophysics, Food Science or related field of study and four (4) years of experience as a Medical Device Auditor, Lead Auditor or related role where required experience gained.

In lieu of a Bachelor’s degree in above stated fields and four (4) years of above stated experience, employer will accept a Master’s degree in Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical engineering or Bioengineering, Human Physiology, Medicine or Veterinary Medicine, Pharmacy, Physics or Biophysics, Food Science or related field of study and two (2) years of experience as a Medical Device Auditor, Lead Auditor or related role where required experience gained.

Special Skills: Also requires experience in the following:

  • Two (2) years of experience in medical device or healthcare industry, medical device audits or research in medical devices;
  • Entire process of auditing medical device quality management systems, including documentation review, risk management of applicable medical devices, implementation audit, and audit reporting with an accredited CB/NB;
  • Participated as a trainee in a minimum of four audits, totaling at least 20 days in an accredited QMS program, with at least 50% of that time against ISO 13485, in an accredited program;
  • Acting in a team leader role under the supervision of a qualified team leader for at least three ISO 13485 audits;
  • ISO 13485:2016 36-40 Hour lead auditor certification;
  • 20 audit days in ISO 9001/ISO 13485 or combination of both as a 3rd party lead auditor;
  • MDR Training;
  • MDSAP Training; and
  • ISO 14971:2019 Training.

#LI##ID##CB#

Benefits

Please note, benefits may depend on your contract type, please confirm with your recruiter.

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.