Quality Systems Engineer • Mid-Level

Who you are

You have a strong background in quality systems engineering, particularly in the context of regulated medical devices. Your experience includes designing and implementing systems that ensure compliance with regulatory standards, and you are adept at embedding compliance into engineering workflows. You possess a systems thinking mindset and are skilled in creative problem-solving, which allows you to build durable compliance infrastructures that support rapid development. You are committed to continuous improvement and optimization of quality systems to enhance speed and reliability in software development.

You understand the complexities of the software lifecycle, from requirements definition through verification, validation, risk management, and release. Your ability to eliminate ambiguity and reduce manual effort is key to your success in this role. You are also a team player who enjoys collaborating with cross-functional teams to achieve common goals and drive impactful results.

What you'll do

As a Quality Systems Engineer, you will be responsible for designing, implementing, and continuously improving software-focused design control systems. Your primary focus will be on ensuring that regulatory compliance is embedded into the architecture of these systems. You will work closely with engineering teams to build systems that support the full software lifecycle, ensuring that all aspects of design controls are addressed effectively. Your role will involve optimizing these systems to improve development speed and reliability, ultimately contributing to the success of safety-critical software products.

You will collaborate with various stakeholders to ensure that the quality systems meet both internal and external regulatory requirements. Your expertise will help guide the team in establishing internal design and quality systems that exceed FDA expectations. You will also play a crucial role in advancing team members, fostering a culture of compliance and quality within the organization.

What we offer

At Neuralink, we provide excellent medical, dental, and vision insurance through a PPO plan, along with paid holidays and commuter benefits. Meals are provided, and we offer equity (RSUs) as part of our compensation package. We also have a 401(k) plan and parental leave policies in place. Our flexible time off policy allows employees to take the time they need to recharge and maintain a healthy work-life balance. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse backgrounds and perspectives.