Demo

Internal Auditor, Quality

Neuralink
Neuralink Salary
Austin, TX Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/18/2025

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 Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.

Job Responsibilities and Description :

  • Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and Neuralink policies
  • Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed
  • Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action
  • Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
  • Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions
  • Lead the front room for external audits (i.e., FDA or other notified bodies)

Required Qualifications :

  • Bachelor's degree in a relevant scientific or healthcare field
  • 4 years of experience as an auditor
  • Experience being in the front room for external audits (FDA or other notified bodies)
  • Experience conducting audits of GLP, GMP, and GCP
  • Working knowledge of FDA regulatory requirements and standards
  • Strong quality assurance and analytical skills
  • Excellent communication and collaboration abilities
  • Experience with regulatory and technical writing
  • Preferred Qualifications :

  • Engineering background
  • Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP)
  • Experience with supplier audits
  • Experience leading an internal audit program
  • Pay Transparency :

    The following details are for Texas individuals only.

    Texas Pay Transparency

    78,000-$119,000 USD

    For Full-Time Employees, your compensation package will include two major components : salary and equity. Guidance on salary for this role will be determined according to the level at which you enter the organization, with the ability to gain more over time as you contribute. In addition, Full-Time Employees are eligible for the following benefits listed below.

    What We Offer :

  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields
  • Growth potential; we rapidly advance team members who have an outsized impact
  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity 401(k) plan
  • Temporary Employees & Interns excluded
  • Parental leave
  • Temporary Employees & Interns excluded
  • Flexible time off
  • Temporary Employees & Interns excluded
  • Salary : $78,000 - $119,000

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