About the role
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. Team Description: Join the Quality Assurance Team, where our mission is to ensure compliance with relevant regulatory standards and the functional, consistent, and reliable operation of our regulated processes. We are a group of industry-experienced professionals who utilize creative problem-solving to identify gaps and help establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance. Job Description &
Responsibilities: 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 and Good Laboratory Practices (GLP), and, when needed, clinical guidelines, manufacturing protocols, and quality control practices.
Responsibilities will include: Conduct audits of Good Laboratory Practice (GLP) activities within Neuralink, and when needed, assist with auditing Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and engineering activities, ensuring adherence to U.S. FDA regulatory
requirements, any applicable international standards, and Neuralink policies Review evidence and issue findings for compliance concerns or deviations Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation Communicate the findings of all QA inspections to appropriate management via signed inspection reports Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions Assist with maintaining a master schedule of all GLP- regulated studies and copies of all approved protocols Assist with compliance initiatives and continuous quality improvement projects, as needed Ensure personnel training records are maintained by staff Assist with FDA inspections Required