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Quality Systems Engineer

Neuralink· Translational
Apply on company site
Austin, TX$71k - $119kFull-timePosted 11mo ago

About the role

Quality Systems Engineer responsible for gathering requirements, developing compliant processes, and driving continuous improvement to ensure ISO 13485 and 21 CFR 820 compliance, with dashboards and metrics to optimize manufacturing, data collection, nonconformance management, audits, and reporting.

Responsibilities

  • Gather requirements and develop processes with compliance built into their design to eliminate variables, save time, and reduce costs for rapid iteration and innovation
  • Continuously optimize and improve processes to enhance efficiency and systemic compliance
  • Develop quantifiable metrics displayed in real-time on a dashboard (e.g., Excel, Grafana, Google Sheets)
  • Drive process improvements to enhance systemic compliance and quality standards
  • Assist with deviation and audit findings, tracking, ensuring effective execution, and coordinating timely closure of actions
  • Own subsets of Quality Systems per ISO 13485 and 21 CFR 820, including Training Management System (Internal & External), Document & Change Control, CAPAs, Deviation Management

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

Skills

Required:Process optimizationData-driven decision making

Benefits

  • Excellent medical, dental, and vision insurance through a PPO plan
  • Paid holidays
  • Commuter benefits
  • Meals provided
  • Equity (RSUs) for full-time employees
  • 401(k) plan
  • Parental leave
  • Flexible time off
Last updated Aug 26, 2026. Interested? Apply on the company site.

About Neuralink

Pioneering Brain Computer Interfaces

Creating a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow.

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