Quality Assurance Specialist
Core
Ensure compliance with regulatory standards (FDA, ISO, GxP) and maintain reliable operations for Neuralink's brain-computer interface devices.
Role type
Quality Assurance Specialist (Regulatory Compliance)
Builds
Compliance systems and audit processes for medical device development
Domain
Medical devices / Biotechnology / Regulatory Affairs
Deliverable
client delivery
Required skills
Auditing (GLP/GMP/GCP), FDA regulatory knowledge, SOP adherence, Deviation tracking, Protocol management, Training record maintenance
Preferred skills
Medical device/pharma experience, External agency audit experience, Scientific method knowledge, Engineering first principles
Technologies
Google Docs, Google Drive, Gmail
Responsibilities
Conduct audits of GLP activities and assist with GMP/GCP audits, Review evidence and issue findings for compliance deviations, Determine authorization status of protocol deviations, Communicate inspection findings via signed reports, Track and close audit/deviation actions, Maintain master schedule of regulated studies, Assist with FDA inspections
Seniority
Entry-level to Junior, hands-on IC
