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. Our vision is to set internal quality standards that exceed FDA expectations.

Job Responsibilities and Description: 

• Conduct audits of GLP, GMP, GCP, and engineering activities within Neuralink, ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and Neuralink policies
• Identify and define audit scope and criteria, review evidence, analyze findings to assess compliance levels, and provide recommendations for improvement and corrective actions as needed
• Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action
• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions
• Lead the front room for external audits (i.e., FDA or other notified bodies)

Required Qualifications: 

• Bachelor’s degree in a relevant scientific or healthcare field
• 4+ years of experience as an auditor
• Experience being in the front room for external audits (FDA or other notified bodies) 
• Experience conducting audits of GLP, GMP, and GCP
• Working knowledge of FDA regulatory requirements and standards
• Strong quality assurance and analytical skills
• Excellent communication and collaboration abilities
• Experience with regulatory and technical writing

Preferred Qualifications:

• Engineering background
• Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP)
• Experience with supplier audits
• Experience leading an internal audit program