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Quality Assurance Audit Lead

2 months ago

Austin, Texas, United States Neuralink Full time
Company Overview:

At Neuralink, we are pioneering the future of brain-computer interfaces, developing innovative devices that aim to assist individuals with paralysis in regaining mobility and independence. Our mission extends to inventing groundbreaking technologies that can enhance human capabilities and foster community growth.

Department Overview:

Become a vital part of the Quality Team, dedicated to ensuring adherence to essential regulatory standards. Our team comprises seasoned professionals who employ inventive problem-solving techniques to create effective compliance systems. We aspire to establish internal quality benchmarks that surpass FDA expectations.

Key Responsibilities:
  • Execute audits for GLP, GMP, GCP, and engineering operations within Neuralink, verifying compliance with U.S. FDA regulations, relevant standards, and company policies.
  • Determine and outline audit scope and criteria, evaluate evidence, analyze results to gauge compliance levels, and suggest enhancements and corrective measures as necessary.
  • Conduct root-cause analysis to pinpoint compliance deficiencies and risks, delivering findings to leadership for further action.
  • Champion process enhancements to improve systemic compliance and quality standards, leveraging creativity and problem-solving expertise.
  • Support the management of deviations and audit findings, ensuring effective resolution and timely closure of actions.
  • Lead the coordination for external audits (e.g., FDA or other regulatory bodies).
Essential Qualifications:
  • Bachelor's degree in a relevant scientific or healthcare discipline.
  • A minimum of 4 years of auditing experience.
  • Experience in leading external audits (FDA or other regulatory bodies).
  • Proficiency in conducting audits of GLP, GMP, and GCP.
  • Comprehensive understanding of FDA regulatory requirements and standards.
  • Strong skills in quality assurance and analysis.
  • Exceptional communication and teamwork capabilities.
  • Experience in regulatory and technical documentation.
Preferred Qualifications:
  • Background in engineering.
  • Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
  • Experience in supplier audits.
  • Proven track record in leading an internal audit program.
Compensation Transparency:

The salary range for this position is $78,000-$119,000 USD for Texas residents.

For Full-Time Employees, the compensation package includes salary and equity, with salary guidance based on the level of entry into the organization, allowing for growth over time. Additionally, Full-Time Employees are eligible for a comprehensive benefits package, including:
  • Opportunities to make a significant impact and collaborate with top-tier experts across various fields.
  • Career advancement potential for team members who demonstrate exceptional contributions.
  • Comprehensive medical, dental, and vision insurance through a PPO plan.
  • Paid holidays and commuter benefits.
  • Provided meals and equity + 401(k) plan (excludes Temporary Employees & Interns).
  • Parental leave and flexible time off (excludes Temporary Employees & Interns).
Neuralink is committed to fostering a diverse workforce and encourages candidates from all backgrounds to apply, even if they do not meet every qualification listed.

We uphold equal opportunity in all employment practices and ensure that all decisions are made without unlawful discrimination. If you require reasonable accommodations during the interview process, please inform us, and we will provide necessary adjustments.