Neuralink
Quality Systems Engineer
About this role
Neuralink seeks a Quality Systems Engineer to design and optimize compliant processes for medical device manufacturing, ensuring FDA regulatory adherence while driving efficiency and innovation. You'll own key quality system components like training management, document control, and deviation tracking while building real-time metrics dashboards.
What you'll do
- Develop and optimize processes with compliance built-in for manufacturing, testing, data collection, and nonconformance management
- Create quantifiable metrics and real-time dashboards (Excel, Grafana, Google Sheets) to track quality system performance
- Own and manage quality system subsets including Training Management, Document & Change Control, CAPAs, and Deviation Management per ISO 13485 and 21 CFR 820
- Drive continuous process improvements using creative problem-solving to enhance systemic compliance and quality standards
- Manage deviation and audit findings, track corrective actions, and coordinate timely closure of findings
- Collaborate across teams to gather requirements and implement systems that eliminate variables and reduce costs
What they're looking for
- Process design and optimization for compliance
- Regulatory knowledge (ISO 13485, 21 CFR 820, FDA requirements)
- Quantitative analysis and metrics development
- Basic coding and database querying
- Dashboard and data visualization tools (Excel, Grafana, Google Sheets)
- Problem-solving and continuous improvement mindset
- Project management and cross-functional collaboration
- Quality systems and CAPA management
Benefits
- Competitive base salary with equity (RSUs) for full-time employees
- Comprehensive medical, dental, and vision insurance (PPO)
- Paid holidays and flexible time off
- 401(k) retirement plan
- On-site meals and commuter benefits
- Parental leave and rapid advancement opportunities for high-impact performers
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Neuralink
Neuralink develops brain-computer interface technology and neurosurgical robots to enable direct interaction between the brain and computing systems. The company is hiring engineers across clinical implementation, user interface design, manufacturing, and software development to support its pioneering medical devices and surgical systems.
- Website
- neuralink.com
Likely interview questions
- Describe a process you've designed or optimized from scratch—how did you identify inefficiencies and measure improvement?
- Walk us through your experience with ISO 13485 or 21 CFR 820 compliance—which elements are you most familiar with?