Quality Assurance Specialist

Future Ventures; Austin (TX); On-site; USD 35,817 - 61,992; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

Paid Holidays

Commuter Benefits

Equity (RSUs)

401(k) Plan

Parental Leave

Flexible Time Off

Job summary

Neuralink in Texas is seeking a Quality Assurance Specialist to ensure adherence to FDA, ISO, GLP, and related standards across our regulated processes. The role collaborates with cross-functional teams to drive compliant, reliable operations in our labs, clinics, and production environments.

The position focuses on audits, documentation, training, and continuous quality improvements, with responsibilities ranging from inspecting GLP activities to supporting FDA inspections and maintaining

Qualifications

• Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline.
• Exposure to a regulated environment (e.g., FDA-regulated industry, GxP, ISO, or quality system work)
• Working knowledge of FDA regulatory requirements and standards
• Excellent communication and collaboration abilities
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to travel to/from work in multistate locations

Responsibilities

• Conduct audits of GLP activities and assist with GMP, GCP, and engineering audits to ensure FDA compliance.
• Review evidence and issue findings for compliance concerns or deviations
• Verify no deviations from approved protocols without proper authorization/documentation
• Communicate QA inspection findings to management via signed reports
• Assist with deviation/audit findings tracking and closure of actions
• Maintain master schedule of GLP-regulated studies and approved protocols

Skills

Communication

Collaboration

Regulatory awareness

Auditing

Education

Bachelor of Science

Tools

Google Docs

Google Drive

Gmail

Job description

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 the 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 & 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 Good Laboratory Practices (GLP), and, when needed, clinical guidelines, manufacturing protocols, and quality control practices. Responsibilities will include:

• Conduct audits of Good Laboratory Practice (GLP) activities within Neuralink, and when needed, assist with auditing Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and engineering activities, ensuring adherence to U.S. FDA regulatory requirements, any applicable international standards, and Neuralink policies
• Review evidence and issue findings for compliance concerns or deviations
• Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation
• Communicate the findings of all QA inspections to appropriate management via signed inspection reports
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions
• Assist with maintaining a master schedule of all GLP‑regulated studies and copies of all approved protocols
• Assist with compliance initiatives and continuous quality improvement projects, as needed
• Ensure personnel training records are maintained by staff
• Assist with FDA inspections

Required Qualifications

• Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline
• Exposure to a regulated environment (e.g., FDA-regulated industry, GxP, ISO, or quality system work)
• Working knowledge of FDA regulatory requirements and standards
• Excellent communication and collaboration abilities
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to travel to/from work in multistate locations

Preferred Qualifications

• Internship, co‑op, or up to 1 year of experience in a medical device, pharmaceutical, or life sciences organization
• 1+ years of experience auditing
• 1+ year of experience within a regulatory environment
• Experience being part of external agency audits (e.g., FDA or other notified bodies)
• Experience following SOPs and documenting work accurately in a controlled process
• Working knowledge of the scientific method and engineering first principles
• Excellent organization and communication skills
• Keen eye for detail

Work Environment

Office, lab, operating room, and animal care facilities

Expected Compensation

At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate 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 Hourly Range: $26.92 — $44.71/Hr 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