Quality Assurance Specialist

Company: Neuralink
Location: Fremont
Posted on: May 16, 2022

Job Description:

Neuralink is seeking candidates with a record of outstanding technical achievement and experience in the area of Good Laboratory Practices and/or 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 become intimately familiar with all relevant study protocols, standard operating procedures, and quality management systems that meet the requirements outlined by domestic (FDA) and international (OECD) regulatory agencies. You will be responsible for performing audits of 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.
• Meticulous attention to detail with a propensity for efficient workflows. Key Qualifications:
  • Familiarity with GLP and/or GMP processes. 1 year experience is preferred. -
  • Familiarity with FDA regulations.
  • A strong understanding of the scientific method and engineering first principles.
  • Strong organization and communication skills.
  • Experience training personnel.
  • Deep understanding of animal care, veterinary medicine, surgery, necropsies and/or histology processes. -

Keywords: Neuralink, Fremont , Quality Assurance Specialist, Other , Fremont, California