Senior Quality Assurance Specialist

Regulatory   ·   Fremont, CA   ·   Full time

Neuralink is developing ultra-high bandwidth brain-machine interfaces to connect humans and computers. We are building a team of multidisciplinary experts passionate about making a world-changing impact.

Neuralink is seeking accomplished candidates with a record of outstanding achievement in the area of quality assurance. In this role you will work with Neuralink’s technical and medical teams to ensure that safety and efficacy studies comply with good laboratory practices and that device manufacturing complies with relevant regulation around design controls and good manufacturing practices. You will be expected to maintain a master schedule of all controlled activities and become intimately familiar with all relevant study plans, standard operating procedures, and quality management systems. You will be responsible for performing audits of manufacturing quality, animal studies, and records, and report your findings directly to stakeholders. Successful candidates will be highly adaptable, detail-oriented, effective communicators, and have a keen sense of urgency.

About you:

• You find large challenges exciting and enjoy discovering and defining problems as much as solving them.
• You deliver. You may enjoy thoughtful conversations about problems and perfecting designs, but in the end, you know that what matters is delivering a manufacturable solution that works every time.
• You are a cross-disciplinary team member. You are excited to work with and learn from software, mechanical, electrical, materials, biological engineers, and neuroscientists. You are comfortable communicating across teams.
• Resourceful, flexible and adaptable; no task is too big or too small.

Key Qualifications:

• Deep experience auditing GLP and/or GMP processes.
• Familiarity with FDA regulations.
• A strong understanding of the scientific method and engineering first principles.
• Strong organization and communication skills.

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields.
• Growth potential. We rapidly advance team members who have an outsized impact.
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.