Full-Time

Quality Systems Specialist

Confirmed live in the last 24 hours

Neuralink

Neuralink

201-500 employees

Develops brain-computer interfaces for medical use

AI & Machine Learning
Biotechnology
Healthcare

Compensation Overview

$70k - $152kAnnually

+ Equity

Junior

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. Their main product, the N1 Implant, is a small, fully implantable device that allows users to control computers or mobile devices. It works by processing neural signals with low-power chips and transmitting the data wirelessly to an application that translates brain activity into 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 goal of Neuralink is to restore autonomy to those with unmet medical needs while exploring the possibilities of human-computer interaction.

Company Stage

N/A

Total Funding

$667.3M

Headquarters

Fremont, California

Founded

2016

Growth & Insights
Headcount

6 month growth

9%

1 year growth

14%

2 year growth

35%
Simplify Jobs

Simplify's Take

What believers are saying

  • Neuralink's pioneering technology has the potential to restore autonomy to individuals with severe mobility issues, offering life-changing benefits.
  • The company's advancements in AI and brain-computer interfacing could position it as a leader in the emerging field of transhumanism.
  • Successful clinical trials and patient testimonials, like those of Noland Arbaugh, can significantly boost Neuralink's credibility and attract more investment.

What critics are saying

  • The complexity and invasiveness of the N1 Implant procedure could deter potential users and slow adoption rates.
  • Ethical concerns and regulatory hurdles surrounding brain implants could pose significant challenges to Neuralink's market entry and expansion.

What makes Neuralink unique

  • Neuralink's N1 Implant is a fully implantable, cosmetically invisible device, setting it apart from other BCIs that may be more cumbersome or visible.
  • The use of a surgical robot for precise implantation of ultra-thin threads minimizes brain damage, a significant advancement over traditional surgical methods.
  • Neuralink's focus on both medical applications and cognitive enhancement broadens its market reach beyond just medical patients.

Help us improve and share your feedback! Did you find this helpful?

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.