Team Description:

Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance.

Job Description and Responsibilities:

The Quality Assurance (QA) Manager will collaborate with Neuralink's teams to ensure that the applicable regulatory requirements (e.g., FDA, ISO) are upheld across company activities. These areas may include lab spaces, preclinical and clinical studies, and manufacturing activities. Additionally, the person in this role will be expected to:

• Lead risk management activities to identify, assess, and mitigate potential risks to quality and compliance within company operations
• Collaborate with internal stakeholders to establish and maintain key performance indicators (KPIs) for quality and compliance metrics
• Manage a team of quality assurance professionals responsible for preclinical and clinical study compliance, and GMP manufacturing compliance
• Review processes, protocols, reports, and other company activities for regulatory compliance
• Serve as a subject matter expert for quality-related inquiries and provide guidance to internal teams on quality matters
• Support the development and maintenance of the company's quality manual, policy, and objectives
• Conduct risk assessments for new product development projects to ensure quality and compliance considerations are addressed
• Lead root cause analysis investigations for quality incidents or deviations to identify underlying issues and implement corrective actions
• Write, review, and approve SOPs to promote adherence to GMP, GCP, and/or GLP processes
• Implement and maintain a robust internal audit program to regularly assess adherence to quality management system requirements
• Coordinate, facilitate, and lead internal and external quality audits by regulatory agencies and third-party auditors

Required Qualifications:

• Bachelor’s Degree in a science, engineering, or quality-related discipline, or equivalent experience
• 3+ years of professional experience in an FDA-regulated environment
• Demonstrated leadership skills
• Excellent communication and collaboration skills
• Strong attention to detail and organizational abilities

Preferred Qualifications:

• Expertise in EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards
• Experience auditing and managing GxP processes