Quality Systems Engineer

Neuralink; Austin (TX); On-site; USD 71,000 - 119,000; Full time

Benefits offered by this job

Equity (RSUs)

Medical, dental, and vision insurance

401(k) plan

Paid holidays

Meals provided

Flexible time off

Parental leave

Job summary

Neuralink seeks a Quality Systems Engineer to design and implement compliant processes that minimize variance, reduce costs, and accelerate rapid iteration in a high-growth environment in Austin, TX. You will own ISO 13485 and 21 CFR 820 subsystems like Training Management, Document & Change Control, CAPAs, and Deviation Management.

You will gather requirements, create real-time metrics dashboards (Excel, Grafana, Google Sheets), and drive continuous improvement across manufacturing, data

Qualifications

• Bachelor's degree in Engineering or a related field.
• Ability to develop and optimize processes for efficiency and compliance.
• Understanding of engineering fundamentals.
• Proficiency in basic coding and querying.
• Strong analytical skills with the ability to create quantifiable metrics.
• Excellent communication and collaboration abilities.
• Problem-solving mindset.

Responsibilities

• Gather requirements and develop compliant processes that reduce variance and costs.
• Design dashboards and quantify metrics for real-time monitoring.
• Drive process improvements to enhance systemic compliance and quality standards.
• Assist with deviation and audit findings and ensure timely closure of actions.

Skills

Process optimization

Data analysis

Coding & querying

Communication

Problem solving

Education

Bachelor's degree in Engineering

Job description

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 Systems Team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to 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:

As a Quality Systems Engineer, your primary responsibility will be to gather requirements and develop processes with compliance built into their design. These processes will eliminate variables, save time, and reduce costs to facilitate rapid iteration and innovation. You will continuously optimize and improve these processes to enhance efficiency over time, moving from one method to another as they are built and optimized. Processes may encompass various areas such as manufacturing, data collection, nonconformance management, automation of audits and reporting, testing, etc.

• Develop quantifiable metrics displayed in real-time on a dashboard of your choice (e.g., Excel, Grafana, Google Sheets)
• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions

You will own subsets of Quality Systems required per ISO 13485 and 21 CFR 820. These include but are not limited to:

• Training Management System (Internal & External)
• Document & Change Control
• CAPAs
• Deviation Management

Required Qualifications:

• Bachelor's degree in Engineering or a related field
• Demonstrated ability to develop and optimize processes for efficiency and compliance
• Understanding of engineering fundamentals
• Proficiency in basic coding and querying
• Strong analytical skills with the ability to create quantifiable metrics
• Excellent communication and collaboration abilities
• Problem-solving mindset

Preferred Qualifications:

• Background in Biomedical or Electrical Engineering
• 1-3 years of experience in Quality Systems
• Experience with Operational Excellence projects
• Familiarity with Six Sigma principles and projects

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.

Base Salary Range:

$71,000 - $119,000 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
• 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