Team info:

Our Mission as the Quality Systems team is to ensure compliance with applicable regulatory standards. We bring industry experience and utilize a creative problem-solving mindset to establish collaborative solid & efficient systems for compliance. The team works to identify and minimize risk while maintaining flexibility and maximizing resource efficiency. Our vision is to have internal quality standards higher than the FDA's expectations.

Job Responsibilities:

The Senior QA Specialist (Clinical) will complete audits and ensure that clinical personnel across Neuralink operate within U.S. FDA regulatory requirements, GCP standards, and Neuralink policies and procedures. The Senior QA Specialist works without appreciable direction and exercises considerable latitude in determining objectives and solutions to various compliance problems. These solutions require regular ingenuity, influence management skills, and creativity. This position applies extensive technical expertise and has full knowledge of other related disciplines. Some responsibilities are:

• Performs ongoing compliance audits using standard evaluation tools for audit/monitoring activities and ensures adherence to regulatory requirements.
• Identifies and defines audit scope and criteria, reviews and analyzes evidence and documents audit findings. Makes recommendations for improvement and correction where identified.
• Provides comprehensive advice to assigned departments regarding compliance risks concerning contract provisions and federal and State regulations.
• Performs root cause analysis when compliance, accreditation, or clinical gaps are identified and provides results to leadership.
• Drive process improvements
• Assists with monitoring activities involving the effective execution of corrective action requirements.
• Coordinates on-time closure of actions.
• May lead clinical quality process improvement initiatives.

Join a diverse team of engineers and specialists who bring their experience, unique backgrounds, and individual problem-solving mindset to collaborate with different teams and ensure quality and compliance higher than the FDA standards.

Key qualifications:

• Bachelor's degree in a relevant scientific or healthcare field.
• 4+ years of experience in clinical quality assurance or related roles.
• Proficient in Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Strong quality assurance and analytical skills.
• Excellent communication and collaboration abilities.
• Experience with regulatory and technical writing.

Preferred qualifications:

• Masters in Regulatory Affairs or Clinical Affairs
• Experience in significant-risk medical device clinical trial
• Experience with international clinical trials (outside the USA).