Internal Audit Lead

3 weeks ago

Austin, Texas, United States Neuralink Full time

Job Title: Internal Audit Lead - Quality Assurance

Job Summary: We are seeking a highly skilled Internal Audit Lead - Quality Assurance to join our Quality Team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and establishing efficient systems for compliance.

Key Responsibilities:

  • Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink to ensure adherence to U.S. FDA regulatory requirements and applicable standards.
  • 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).

Requirements:

  • 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.

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.

Neuralink is an equal opportunity employer and welcomes candidates of all backgrounds.

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