IVD Medical Lead Auditor – (Mid-USA & West Coast)

Location US-IL-Northbrook
Job ID
# of Openings
Job Category


LHS – Medical Devices – Safer World

At UL, we know why we come to work.

Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure, and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion, and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely!


As our global footprint continues to grow, we are looking for a Lead Auditor to join our Medical Devices team to service our clients in the central and western sections of the US. This could be in the Midwest, Texas, or west coast, etc. This position can be located remotely anywhere within this geographic area. 

What you’ll learn & achieve:

  • Support regular quality system and technical audits, including CE unannounced audits.
  • Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses.
  • Subject to training and qualification milestones, perform key Quality Management System audit activities to support safe products to market.
  • Support Competent Authority activities on as needed basis e.g., Competent Authority audits of UL.
  • Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
  • Provide guidance and support to customers as required. Participate in client training and customer forums.
  • Performs other duties as directed.

What makes you a great fit:

  • University or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering, or other relevant sciences
  • Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in quality management
  • Appropriate knowledge:
    • Devices legislation as well as related harmonized standards, CS, and guidance documents
    • Risk management and related device standards and guidance documents
    • Quality management systems and related standards and guidance documents
    • Conformity assessment procedures in the listed programs (MDSAP, ISO13485, IVD, IVDR, etc.) of the aspects of those procedures for which they are responsible, and adequate authorization for carrying out those audits
    • Useful experience may include testing, design and development, manufacturing, quality assurance, or monitoring experiences with a focus on In-vitro Diagnostic processes and products.
  • Training in auditing techniques enabling them to challenge quality management systems
  • Ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out
  • Ability to travel domestically and internationally (50-75%)
  • UL has COVID-19 protocols and policies in place to ensure the safety of our employees, customers, and clients. Effective November 1, 2021, the company mandates that employees are vaccinated against COVID-19 as a condition of employment (except where prohibited by law), subject to reasonable accommodation as required by law.

What you’ll experience working at UL:

  • Mission: For UL, corporate and social responsibility isn’t new.  Making the world a safer, more secure, and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do.
  • People: Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL.  We’re able to deliver the best because we employ the best.
  • Interesting work: Every day is different for us here as we eagerly anticipate the next innovation that our customers create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
  • Grow & achieve: We learn, work, and grow together with targeted development, reward, and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
  • Total Rewards: In the US, we provide lots of great benefits for our employees are their families. From Volunteer Days off to 401k match and retirement contribution benefits to flexible work location & schedule options we look to support our employees no matter what stage in life they are experiencing. 

Learn More:

Working at UL is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.


Curious? To learn more about us and the work we do, visit UL.com 


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If you wish to request reasonable accommodation at any time, please email our Talent Acquisition team at Talent.Acquisition@ul.com.

UL is an Equal Opportunity Employer: Female/Minority/disability/Protected Veteran/Sexual Orientation/Gender Identity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. If you'd like more information about your EEO rights as an applicant under the law, please review the EEO is the Law and EEO is the Law Supplement.

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UL EEO Policy

Pay Transparency Statement

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