Internal Audit Lead, Quality Assurance Specialist

3 days ago


Fremont, California, United States Neuralink Full time
Job Summary

We are seeking a highly skilled Internal Audit Lead, Quality Assurance Specialist 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.

Key Responsibilities
  • Conduct Audits: 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: 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: Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action.
  • Drive Process Improvements: Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
  • Assist with Deviation and Audit Findings: Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
  • Lead External Audits: Lead the front room for external audits (i.e., FDA or other notified bodies).
Requirements
  • Bachelor's Degree: Bachelor's degree in a relevant scientific or healthcare field.
  • Experience: 4+ years of experience as an auditor.
  • Regulatory Experience: Experience being in the front room for external audits (FDA or other notified bodies).
  • GLP, GMP, and GCP Experience: Experience conducting audits of GLP, GMP, and GCP.
  • Regulatory Knowledge: Working knowledge of FDA regulatory requirements and standards.
  • Quality Assurance and Analytical Skills: Strong quality assurance and analytical skills.
  • Communication and Collaboration: Excellent communication and collaboration abilities.
  • Regulatory and Technical Writing: Experience with regulatory and technical writing.
Preferred Qualifications
  • Engineering Background: Engineering background.
  • International Regulatory Experience: Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
  • Supplier Audits: Experience with supplier audits.
  • Internal Audit Program Leadership: Experience leading an internal audit program.
Compensation and Benefits

Based on California law, the following details are for California individuals only:

California base salary range: $103,000-$169,000 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:

  • Medical, Dental, and Vision Insurance: Excellent medical, dental, and vision insurance through a PPO plan.
  • Paid Holidays: Paid holidays.
  • Commuter Benefits: Commuter benefits.
  • Meals Provided: Meals provided.
  • Equity and 401(k) Plan: Equity + 401(k) plan *Temporary Employees & Interns excluded.
  • Parental Leave: Parental leave *Temporary Employees & Interns excluded.
  • Flexible Time Off: Flexible time off *Temporary Employees & Interns excluded.


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