Quality Systems Engineer

Quality Systems EngineerWe 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.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.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 skillsAssist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actionsYou 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 ControlCAPAsDeviation ManagementRequired Qualifications:Bachelor's degree in Engineering or a related fieldDemonstrated ability to develop and optimize processes for efficiency and complianceUnderstanding of engineering fundamentalsProficiency in basic coding and queryingStrong analytical skills with the ability to create quantifiable metricsExcellent communication and collaboration abilitiesHunger for continuous improvementProblem-solving mindsetPreferred Qualifications:Background in Biomedical or Electrical Engineering1-3 years of experience in Quality SystemsExperience with Operational Excellence projectsFamiliarity with Six Sigma principles and projectsThe 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 USDFull-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 fieldsGrowth potential; we rapidly advance team members who have an outsized impactExcellent medical, dental, and vision insurance through a PPO planPaid holidaysCommuter benefitsMeals providedEquity (RSUs) *Temporary Employees & Interns excluded401(k) plan *Interns initially excluded until they work 1,000 hoursParental leave *Temporary Employees & Interns excludedFlexible time off *Temporary Employees & Interns excluded