Quality Assurance Specialist

Team Description:

Join the Quality Assurance Team, where our mission is to ensure compliance with relevant regulatory standards and the functional, consistent, and reliable operation of our regulated processes. We are a group of industry-experienced professionals who utilize creative problem-solving to identify gaps and help establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.

Job Description & Responsibilities:

The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards and Good Laboratory Practices (GLP), and, when needed, clinical guidelines, manufacturing protocols, and quality control practices. Responsibilities will include:

• Conduct audits of Good Laboratory Practice (GLP) activities within Neuralink, and when needed, assist with auditing Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and engineering activities, ensuring adherence to U.S. FDA regulatory requirements, any applicable international standards, and Neuralink policies
• Review evidence and issue findings for compliance concerns or deviations
• Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation
• Communicate the findings of all QA inspections to appropriate management via signed inspection reports
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions
• Assist with maintaining a master schedule of all GLP- regulated studies and copies of all approved protocols
• Assist with compliance initiatives and continuous quality improvement projects, as needed
• Ensure personnel training records are maintained by staff
• Assist with FDA inspections

Required Qualifications:

• Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline
• Exposure to a regulated environment (e.g., FDA-regulated industry, GxP, ISO, or quality system work)
• Working knowledge of FDA regulatory requirements and standards
• Excellent communication and collaboration abilities
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to travel to/from work in multistate locations

Preferred Qualifications:

• Internship, co-op, or up to 1 year of experience in a medical device, pharmaceutical, or life sciences organization
• 1+ years of experience auditing
• 1+ year of experience within a regulatory environment
• Experience being part of external agency audits (e.g., FDA or other notified bodies)
• Experience following SOPs and documenting work accurately in a controlled process
• Working knowledge of the scientific method and engineering first principles
• Excellent organization and communication skills
• Keen eye for detail

Work Environment: Office, lab, operating room, and animal care facilities

Expected Compensation:

At Neuralink, your base pay is one part of your total compensation package. The anticipated hourly rate for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

Texas Hourly Range:

$26.92 — $44.71/Hr USD