Senior Auditor Medical Device 13485 - Independent Contractor

NSF; Ann Arbor (MI); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading certification organization is seeking two certified Independent Contractor Medical Device ISO 13485 Lead Auditors. This role involves providing audit services, leading audits, and requires extensive travel throughout North America. Candidates must have relevant certifications, be authorized to work in the U.S., and work independently from their home location.

Qualifications

• Must be authorized to work in the United States on an unlimited basis without sponsorship.
• Experience in medical device audits is desired.
• Must have their own business entity.

Responsibilities

• Provide audit, advisory, and associated services to customers.
• Plan and conduct all assessment activities including various types of audits.
• Lead audits of medical devices and companies.

Skills

Medical device auditing

ISO 13485 knowledge

Risk management

Independent work

Traveling

Education

Completion of accredited 13485 Lead Auditor class

ISO 9001:2015 certification

Job description

Senior Auditor Medical Device 13485 - Independent Contractor

Job Description

NSF is seeking two certified and experienced Independent Contractor Medical Device ISO13485 Lead Auditors to work from remotely and travel throughout North America specifically on the West Coast and the Mid-West.

Responsibilities

• Provide audit, advisory and associated services to customers regarding assigned standards and applicable registration program requirements
• Plan and conduct all assessment activities, including documentation reviews (desk audits), preliminary assessments (baseline audits), On-site Readiness Reviews, registration audits, and surveillance audits
• Participate in the selection of audit team members as needed
• Lead audits of medical devices and medical device companies
• 10-15 days per month on average

Qualifications

• Completion of accredited 13485 Lead Auditor class
• For 13485, this is clarified to mean appropriate knowledge and skills of “medical devices and applicable legal requirements”
• Completed training on medical device risk management (e.g. ISO 14971)
• Completed ISO9001:2015 certification or willing to obtain
• Ability to travel
• Own business entity
• Ability to show an audit log
• Willingness and ability to work independently
• Travel extensively throughout North America
• Will pursue advancement of those credentials and other related credentials as needed
• Position based from your home location, relocation not required
• Must be authorized to work in the United States on an unlimited basis without sponsorship

About Us

With a legacy spanning more than 80 years, NSF leverages science and innovation to improve human and planet health. We provide science-driven, independent testing, inspection, certification, and advisory services and develop the very standards that drive the food, water, and life sciences industries worldwide. We empower our clients to navigate shifting regulations to improve consumer health, safety, and quality of life.

One of our core values is We Are One NSF. This means that while we’re one team, we embrace the cultural, ethnic, language, and demographic diversity that reflects the societies in which we live and work.

Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org.

NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

Notice to Agency and Search Firm Representatives: Please note that NSF is not accepting unsolicited resumes from agencies/search firms for this role. Resumes submitted to an NSF employee by a third-party agency without a valid written & signed search agreement between NSF and said third-party agency will become the sole property of NSF. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral. Thank you.

About the Team

NSF provides a holistic suite of value-added digital, information security and sustainability solutions that span our core industries of food, water and life sciences. Our client-focused teams have deep industry expertise and are committed to supporting the journey to certification, helping to empower organizations to drive process and performance improvements for products, people, and the planet.

Job Info

• Job Identification 3193
• Job Category Audit and Inspection
• Posting Date 09/24/2025, 08:39 PM
• Job Schedule Full time