Internal Audit Lead, Quality Assurance

1 week ago

Austin, Texas, United States Neuralink Full time
Job Title: Internal Audit Lead, Quality

We are seeking a highly skilled Internal Audit Lead 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 driving process improvements to enhance systemic compliance and quality standards.

Responsibilities:
  • Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring 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 provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.

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