Full-Time

Quality Systems Specialist

Confirmed live in the last 24 hours

Neuralink

Neuralink

501-1,000 employees

Develops brain-computer interfaces for medical use

Robotics & Automation
AI & Machine Learning
Healthcare

Compensation Overview

$70k - $125kAnnually

+ Equity

Junior, Mid

Austin, TX, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • Bachelor of Science in Engineering or a related field
  • 1-2 years of experience in a medical device industry
  • Experience and knowledge of ISO 13485 and 21 CFR 820 requirements
  • Problem-solving mindset
  • Strong written and oral communication skills
  • High attention to detail
  • Basic understanding of statistical tools and analysis of trend data
Responsibilities
  • Acting as a subject matter expert and working cross-functionally with our various teams
  • Leading the CAPAs and supporting additional CAPA owners for timely completion, adequate root cause analysis, and deploying necessary corrective and preventive actions
  • Serving as the nonconformance coordinator, ensuring timely completion and compliance for preclinical, manufacturing, clinical, and process NCRs
  • Building KPIs and trend data at a regular cadence as well as making data-driven decisions to reduce the occurrence of defects/NCRs across the company
  • Owning document change control and document reviews, facilitating procedure updates with process owners, and improving the existing design and automating the process
  • Creating a data storage system, keeping it up to date and organized, and performing regular data storage and access audits
  • Leveraging operational experience to meet quality and regulatory goals and defining processes within a Quality System
  • Drafting SOPs and Work Instructions and establishing training processes as applicable
  • Supporting back room & front room audits

Neuralink develops brain-computer interfaces (BCIs) that enable direct communication between the brain and external devices. Its main product, the N1 Implant, is a small, fully implantable device that allows users to control computers or mobile devices. The implant works by processing neural signals with custom low-power chips and transmitting the data wirelessly to a dedicated application, which translates brain activity into computer commands. What sets Neuralink apart from competitors is its focus on both medical applications for individuals with mobility issues and the potential for cognitive enhancement for a broader audience. The company's goal is to restore autonomy to those with unmet medical needs while exploring the possibilities of human-computer interaction.

Company Stage

Series D

Total Funding

$667.3M

Headquarters

Fremont, California

Founded

2016

Growth & Insights
Headcount

6 month growth

14%

1 year growth

19%

2 year growth

42%
Simplify Jobs

Simplify's Take

What believers are saying

  • Approval for brain-chip tests in Canada opens international expansion opportunities.
  • The $14.7 million Texas facility indicates commitment to scaling operations.
  • Blindsight device development taps into a new market segment for vision restoration.

What critics are saying

  • Increased competition from startups like Inbrain challenges Neuralink's market position.
  • SEC investigation into potential securities fraud could harm reputation and finances.
  • Expansion into new markets introduces regulatory challenges and potential deployment delays.

What makes Neuralink unique

  • Neuralink's N1 Implant is a cosmetically invisible, fully implantable brain-machine interface.
  • The company uses advanced surgical robots for precise and safe implant procedures.
  • Neuralink's Blindsight device aims to restore vision for the blind, diversifying its offerings.

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Benefits

An opportunity to change the world and work with some of the smartest and the 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; parental leave.

Flexible time off + paid holidays.

Equity + 401(k) plan.

Commuter Benefits.

Meals provided.