Medical Device Auditor (13485) - Independent Contractor

The Independent Contract Medical Device Auditor (13485) will conduct 3rd party audits and associated services to NSF's customers regarding assigned standards and applicable registration program requirements. This role will focus on audits for ISO 13485 and more specifically clients of non-implantable and IVD. You will also be responsible for communicating effectively with external clients and internal Account Managers.

• Perform 3rd party onsite/remote audits for ISO 13485 Management systems for North American Customers
• Provide 3rd party audits 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, reassessment, and surveillance audits
• Lead audit team and be responsible for successful accomplishment of assigned projects
• Build professional relationships with NSF clients
• Review and forward audit reports, client responses to audit nonconformities, and other necessary technical documentation.
• Maintain Schedule of audit activities 
• Uphold appropriate auditor credentials and other related credentials as needed
• Attend any additional training needed related to business needs
• Perform other duties as requested by Audit Management team
• Communicates effectively with clients, and account managers
• Contribute to the growth and development of a world-class, industry leading auditing team

 

 

• Completion of accredited 13485 Lead Auditor class
• Medical Industry Experience
• Bachelor’s degree in a related field (i.e., Engineering, Bioscience, Biomedical, Science, etc.) 
• Minimum of 4 years of experience auditing for ISO 13485 standard
• For 13485, this is clarified to mean appropriate knowledge and skills of “medical devices and applicable legal requirements”
• Previous experience with Active Medical Devices (non-implantable) and In Vitro Diagnostics (IVD)
• Completed training on medical device risk management (e.g. ISO 14971)
• Previous 13485 3rd party auditing experience
• Completed ISO 9001:2015 certification or willing to obtain
• Will pursue advancement of those credentials and other related credentials as needed
• Ability to show an audit log
• Willingness and ability to work independently
• Ability to travel extensively throughout North America
• Position based from your home location, relocation not required

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 worlwide. 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 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.