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.

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• Lead ISO 13485 audits for medical device manufacturers, suppliers, and sterilization service providers
• Conduct 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
• Evaluate sterilization quality systems, validation programs, environmental controls, and contamination control strategies
• Assess compliance with applicable sterilization standards, regulatory requirements, and industry best practices
• Provide expert guidance on ISO 13485 requirements and applicable regulatory expectations
• Collaborate in the selection and coordination of audit team members as needed.
• Lead audits of medical devices, medical device manufacturers, and sterilization service providers
• Deliver high-quality audit services while building strong client relationships

The 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) Sterilization
• Radiation Sterilization (Gamma, Electron Beam, and X-ray)
• Moist Heat / Steam Sterilization
• Dry Heat Sterilization
• Chemical Sterilization Processes
• Aseptic Processing and Sterile Barrier Systems
• Cleaning, disinfection, and contamination control processes

The auditor should be familiar with developing, implementing, validating, and routinely monitoring sterilization processes in accordance with recognized international standards.

• Completion of an accredited ISO 13485 Lead Auditor training course
• Strong knowledge of medical devices and applicable regulatory requirements
• Previous ISO 13485 auditing experience
• Training in medical device risk management (e.g., ISO 14971)
• Demonstrated expertise in medical device sterilization processes, sterilization validation, and contamination control
• Experience auditing sterilization processes and/or managing sterilization programs within a medical device manufacturing environment
• Working 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 documents
• Strong understanding of process validation, microbiology, environmental monitoring, and contamination control principles
• Completed ISO 9001:2015 certification or willingness to obtain
• Ability to maintain and provide an audit log
• Own business entity
• Ability to work independently and manage a flexible schedule
• Willingness and ability to travel extensively throughout North America
• Authorization to work in the United States on an unrestricted basis without sponsorship
• Approximately 10 to 15 audit days per month on average