- 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 and criteria, review evidence, and analyze findings to assess compliance levels. 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.
- 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.
- Engineering background.
- Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
- Experience with supplier audits.
- 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
- Documents in alternate formats or read aloud to you
- Having interviews in an accessible location
- Being accompanied by a service dog
- Having a sign language interpreter present for the interview
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Internal Audit Lead - Fremont, United States - Neuralink
Description
Company Description:We are creating the future of brain-computer interfaces: building devices now that have the potential to help people with paralysis regain mobility and independence and invent new technologies that could expand our abilities, our community, and our world.
Team Description:
Join our Quality Systems team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.
Job Responsibilities and Description:
Based on California law, the following details are for California individuals only:
California base salary range:
$84,420-$188,546 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 listed below.
What We Offer:
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. 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 such employment decisions will be made without unlawfully discriminating on any prohibited basis.
If you need a reasonable accommodation at any point in the interview process, please let us know. Reasonable accommodations are modifications or adjustments to the application or hiring process that would enable you to fully participate in those processes. Examples of reasonable accommodations include but are not limited to:
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