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) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards, Good Laboratory Practices (GLP), clinical guidelines, manufacturing protocols, and quality control practices. Responsibilities will include:

Maintaining copies of all approved protocols
Maintaining a master schedule of all GLP- regulated studies
Performing pre-qualification inspections of the testing facilities as needed
Providing general periodic status reports to management and the study director pertaining to facility, quality control, and preclinical study compliance
Inspecting and auditing at intervals adequate to ensure the integrity of the data and verify applicable compliance
Communicating the findings of all QA inspections to appropriate management via signed inspection reports
Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation
Reviewing study protocols to ensure compliance before study initiation
Verifying that final study reports accurately reflect the raw data, protocol, methods, and SOPs used in conducting the GLP study
Preparing a Quality Assurance Statement to be included in final reports
Writing and reviewing Quality Assurance SOPs
Reviewing equipment, software, and other computer-system validations and qualifications when applicable
Inspecting critical vendors
Ensuring personnel training records are maintained by staff
Conduct GLP training for staff as needed, such as for new hires or when training certifications have expired
Serving as a point of contact and assisting with FDA inspections

Required Qualifications:

Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline
Minimum of 1 year of experience in a medical device or life sciences organization
Minimum of 1 year of experience within a regulatory environment
Minimum of 1 year of experience with FDA regulations and requirements
Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
Ability to travel to/from work in multi-state locations

Preferred Qualifications:

Experience auditing multiple GxP processes
Experience with auditing quality control testing
Strong understanding of the scientific method and engineering-first principles
Understanding within the fields of microbiology and chemistry
Excellent organization and communication skills
Keen eye for detail

Expected Compensation:

The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.

Base Salary Range:

$71,000—$119,000 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 (RSUs) *Temporary Employees & Interns excluded
401(k) plan *Interns initially excluded until they work 1,000 hours
Parental leave *Temporary Employees & Interns excluded
Flexible time off *Temporary Employees & Interns excluded

Quality Assurance Specialist