Quality Assurance Intern

Neuralink

Dec 2, 2023

Applications are closed

Internship
Full-time
Off-cycle Internship
Data
£0
Austin

Requirements

Undergraduate degree in a scientific discipline (e.g. life sciences, chemistry, biology, biotechnology, materials science), OR currently pursuing a graduate degree in a STEM field or in Regulatory Affairs.
Must have strong written and oral communication skills, and enjoy independent learning, doing research, and presenting on a wide variety of topics.
A strong understanding of the scientific method and engineering first principles.
Enjoys working in a collaborative environment with a mission first, go-getter attitude
Preferred qualifications:
Experience of 0-2 years in FDA regulated industry (Medical Devices or Biotechnology)
Experience of 0-1 years in Quality Assurance or Quality Control

Responsibilities

Become intimately familiar with GLPs, QA standard operating procedures (SOPs), FDA audit checklists, and the medical device regulatory process from research and development to first-in-human.
Interact with technical specialists to assist with writing, editing, and performing with mock GLP audits to tune technical and equipment SOPs such that they comply with good laboratory practices.
Create GLP and regulatory training materials, training presentations, and training records.
Assist with setting up and maintaining document control for controlled documents, which includes: obtaining management approval signatures, photocopying, creating SOP and work station binders, ensuring the proper procedures for controlled documents are followed, etc.
Performing procedures, facility, and equipment audits for GLP compliance.
Assist with creating GLP and regulatory infrastructure (systems), which includes: surgical material lot tracking, reagent and solution tracking, sample / specimen tracking, document tracking and retention, etc.
Assist with and/or fill in for various scribe and documentation roles over the course of the GLP study as needed to ensure GLP and regulatory compliance.
Perform literature searches, summarize pertinent information, and apply information to meet Neuralink needs and goals.

Neuralink

Science & Healthcare

Industry

201-500

Employees

2016

Founded Year

Mission & Purpose

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.