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Internal Audit Lead, Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Internal Audit Lead to join our Quality Assurance team at Neuralink. As a key member of our team, you will be responsible for ensuring compliance with relevant regulatory standards and driving process improvements to enhance systemic compliance and quality standards.
Key Responsibilities- Conduct Audits: 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: 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: Perform root-cause analysis to identify compliance gaps and risks, providing results to leadership for further action.
- Drive Process Improvements: Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
- Assist with Deviation and Audit Findings: Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
- Lead External Audits: Lead the front room for external audits (i.e., FDA or other notified bodies).
- Bachelor's Degree: Bachelor's degree in a relevant scientific or healthcare field.
- Experience: 4+ years of experience as an auditor.
- Regulatory Experience: Experience being in the front room for external audits (FDA or other notified bodies).
- GLP, GMP, and GCP Experience: Experience conducting audits of GLP, GMP, and GCP.
- Regulatory Knowledge: Working knowledge of FDA regulatory requirements and standards.
- Quality Assurance and Analytical Skills: Strong quality assurance and analytical skills.
- Communication and Collaboration: Excellent communication and collaboration abilities.
- Regulatory and Technical Writing: Experience with regulatory and technical writing.
- Engineering Background: Engineering background.
- International Regulatory Experience: Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
- Supplier Audits: Experience with supplier audits.
- Internal Audit Program Leadership: Experience leading an internal audit program.
Neuralink offers a competitive compensation package, including a salary range of $78,000-$119,000 USD, and a comprehensive benefits package, including medical, dental, and vision insurance, paid holidays, commuter benefits, meals provided, equity, and a 401(k) plan.
