About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
Join the Quality 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.
Job Description and Responsibilities:
The Quality Assurance (QA) Manager will collaborate with Neuralink's teams to ensure that the applicable regulatory requirements (e.g., FDA, ISO) are upheld across company activities. These areas may include lab spaces, preclinical and clinical studies, and manufacturing activities. Additionally, the person in this role will be expected to:
- Lead risk management activities to identify, assess, and mitigate potential risks to quality and compliance within company operations
- Collaborate with internal stakeholders to establish and maintain key performance indicators (KPIs) for quality and compliance metrics
- Manage a team of quality assurance professionals responsible for preclinical and clinical study compliance, and GMP manufacturing compliance
- Review processes, protocols, reports, and other company activities for regulatory compliance
- Serve as a subject matter expert for quality-related inquiries and provide guidance to internal teams on quality matters
- Support the development and maintenance of the company's quality manual, policy, and objectives
- Conduct risk assessments for new product development projects to ensure quality and compliance considerations are addressed
- Lead root cause analysis investigations for quality incidents or deviations to identify underlying issues and implement corrective actions
- Write, review, and approve SOPs to promote adherence to GMP, GCP, and/or GLP processes
- Implement and maintain a robust internal audit program to regularly assess adherence to quality management system requirements
- Coordinate, facilitate, and lead internal and external quality audits by regulatory agencies and third-party auditors
Required Qualifications:
- Bachelor’s Degree in a science, engineering, or quality-related discipline, or equivalent experience
- 3+ years of professional experience in an FDA-regulated environment
- Demonstrated leadership skills
- Excellent communication and collaboration skills
- Strong attention to detail and organizational abilities
Preferred Qualifications:
- Expertise in EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards
- Experience auditing and managing GxP processes
Expected Compensation:
At Neuralink, your base pay is one part of your total compensation package. The anticipated base salary for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.Texas Base Salary Range$95,000—$176,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- 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
