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Lead Auditor for Quality Assurance

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 new technologies that can enhance our capabilities, foster community, and expand our world.

Department Overview:

Become a 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 of 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 findings to gauge compliance levels, and offer recommendations for enhancements and corrective measures as necessary.
  • Conduct root-cause analysis to pinpoint compliance deficiencies and risks, presenting findings to leadership for further action.
  • Champion process enhancements to improve systemic compliance and quality standards, utilizing creativity and problem-solving skills.
  • Support the management of deviations and audit findings, ensuring effective execution and timely resolution of actions.
  • Lead the front room during external audits (e.g., FDA or other notified bodies).
Required Qualifications:
  • Bachelor's degree in a relevant scientific or healthcare discipline.
  • A minimum of 4 years of auditing experience.
  • Experience in leading the front room for external audits (FDA or other notified 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 collaboration skills.
  • 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.
  • Experience in leading an internal audit program.
Compensation 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 primary components: salary and equity. Salary guidance for this role will be determined based on the level at which you enter the organization, with opportunities for growth over time as you contribute. Additionally, Full-Time Employees are eligible for the benefits listed below.

Benefits Offered:
  • An opportunity to impact the world and collaborate with some of the brightest and most talented experts across various fields.
  • Growth potential; we quickly promote team members who demonstrate significant impact.
  • Comprehensive 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 committed to equal opportunity in all employment practices for 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. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. All employment decisions will be made without unlawful discrimination on any prohibited basis.

If you require reasonable accommodations at any point in the interview process, please inform us. Reasonable accommodations are modifications or adjustments to the application or hiring process that would enable you to fully participate in those processes.