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Form of workTeam Description:
Join our Quality Systems 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, and analyze findings to assess compliance levels. 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.
