Quality Systems Engineer – Regulatory & Process Excellence

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

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