Quality Assurance Specialist

The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards, Good Laboratory Practices (GLP), clinical guidelines, manufacturing protocols, and quality control practices. Responsibilities will include: Maintaining copies of all approved protocols; Maintaining a master schedule of all GLP-regulated studies; Performing pre-qualification inspections of the testing facilities as needed; Providing general periodic status reports to management and the study director pertaining to facility, quality control, and preclinical study compliance; Inspecting and auditing at intervals adequate to ensure the integrity of the data and verify applicable compliance; Communicating the findings of all QA inspections to appropriate management via signed inspection reports; Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation; Reviewing study protocols to ensure compliance before study initiation; Verifying that final study reports accurately reflect the raw data, protocol, methods, and SOPs used in conducting the GLP study; Preparing a Quality Assurance Statement to be included in final reports; Writing and reviewing Quality Assurance SOPs; Reviewing equipment, software, and other computer-system validations and qualifications when applicable; Inspecting critical vendors; Ensuring personnel training records are maintained by staff; Conducting GLP training for staff as needed, such as for new hires or when training certifications have expired; Serving as a point of contact and assisting with FDA inspections.