Senior Auditor Medical Device 13485 - Independent Contractor (East Coast)

NSF is seeking a certified Independent Contractor Medical Device ISO 13485 Lead Auditor with expertise in medical device sterilization processes to join our growing team. This remote opportunity offers flexibility, independence, and the chance to work with leading medical device manufacturers, sterilization providers, and suppliers across North America.The ideal candidate is a recognized sterilization specialist with hands-on experience validating, controlling, and auditing one or more sterilization modalities, and a strong understanding of associated international standards, regulatory requirements, and quality system expectations.#LI-EA1With 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. 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. Completion of an accredited ISO 13485 Lead Auditor training courseStrong knowledge of medical devices and applicable regulatory requirementsPrevious ISO 13485 auditing experienceTraining in medical device risk management (e.g., ISO 14971)Demonstrated expertise in medical device sterilization processes, sterilization validation, and contamination controlExperience auditing sterilization processes and/or managing sterilization programs within a medical device manufacturing environmentWorking knowledge of applicable sterilization standards, including but not limited to: ISO 11135 (Ethylene Oxide Sterilization)ISO 11137 (Radiation Sterilization)ISO 17665 (Moist Heat Sterilization)ISO 14937 (General Requirements for Sterilization Process Validation)ISO 11737-1 and ISO 11737-2 (Bioburden and Sterility Testing)ISO 11607 (Packaging for Terminally Sterilized Medical Devices)AAMI and applicable FDA sterilization guidance documentsStrong understanding of process validation, microbiology, environmental monitoring, and contamination control principlesCompleted ISO 9001:2015 certification or willingness to obtainAbility to maintain and provide an audit logOwn business entityAbility to work independently and manage a flexible scheduleWillingness and ability to travel extensively throughout North AmericaAuthorization to work in the United States on an unrestricted basis without sponsorshipApproximately 10 to 15 audit days per month on averageLead ISO 13485 audits for medical device manufacturers, suppliers, and sterilization service providersConduct audit, advisory, and associated services to customers regarding assigned standards and applicable registration program requirementsPlan and conduct all assessment activities, including documentation reviews (desk audits), preliminary assessments (baseline audits), On-site Readiness Reviews, registration audits, and surveillance auditsEvaluate sterilization quality systems, validation programs, environmental controls, and contamination control strategiesAssess compliance with applicable sterilization standards, regulatory requirements, and industry best practicesProvide expert guidance on ISO 13485 requirements and applicable regulatory expectationsCollaborate in the selection and coordination of audit team members as needed.Lead audits of medical devices, medical device manufacturers, and sterilization service providersDeliver high-quality audit services while building strong client relationshipsThe successful candidate should possess expertise in one or more of the following sterilization technologies and demonstrate a broad understanding of all major sterilization modalities used in the medical device industry:Ethylene Oxide (EO) SterilizationRadiation Sterilization (Gamma, Electron Beam, and X-ray)Moist Heat / Steam SterilizationDry Heat SterilizationChemical Sterilization ProcessesAseptic Processing and Sterile Barrier SystemsCleaning, disinfection, and contamination control processesThe auditor should be familiar with developing, implementing, validating, and routinely monitoring sterilization processes in accordance with recognized international standards.Full timePosting Date: 2026-09-08