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 Assurance Team, where our mission is to ensure compliance with relevant regulatory standards and ensure functional, consistent, and reliable operation of our regulated processes. We are a group of industry-experienced professionals who utilize creative problem-solving to identify gaps and help establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.
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 and the GLPs. 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 studies at critical phases and communicating findings to appropriate management
- 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 and preparing a Quality Assurance Statement to be included in the report
- 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
- 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 multistate locations
Preferred Qualifications:
- Experience auditing GLP processes
- Experience with auditing
- 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
Work Environment: Office, lab, operating room, and animal care facilities
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.
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
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What We Do
Neuralink is a team of exceptionally talented people. We are creating the future of brain-machine interfaces: building devices now that will help people with paralysis and inventing new technologies that will expand our abilities, our community, and our world. Our goal is to build a system with at least two orders of magnitude more communication channels (electrodes) than current clinically-approved devices. This system needs to be safe, it must have fully wireless communication through the skin, and it has to be ready for patients to take home and use on their own. Our device, called the Link, will be able to record from 1024 electrodes and is designed to meet these criteria.
