Quality Systems Engineer
Neuralink · Austin, TX
- Level
- Engineer
- Team
- Quality
- Degree
- Required
- Experience asked
- 3+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Neuralink (medical devices) in Austin, TX. Your primary responsibility will be to gather requirements and develop processes with compliance built into their design.
- They ask for
- 3+ years · degree required
- Tools it names
- Six Sigma, ISO 13485, FDA / GMP, Automation
- Day to day
- some off-shift / weekend coverage
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About the role
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
- ✓Hunger for continuous improvement
- ✓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
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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 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
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