Quality Systems Specialist

Team Description:

The Quality Systems Team is responsible for implementing and operating a compliant system that meets all FDA regulations and supports faster iteration for Neuralink. The goal is to have better and higher safety standards than the FDA, but to ensure innovation and rapid iteration are supported by the systems and processes built by the Quality Systems Team. The Quality Systems team at Neuralink covers the entire GxP landscape, i.e., GLP for preclinical and laboratory studies, GCP for domestic and international clinical trials, and GMP for manufacturing controls. We are a dedicated group of highly skilled professionals who challenge existing requirements with first principles and develop unique ways of solving product and process problems.

Job Description and Responsibilities:

As a Quality Systems Specialist, you will work with teams across the Neuralink organization to resolve isolated and systemic problems through NCRs and CAPAs. You’ll identify ways to trend defects and issues for broader audiences and leadership. This role involves communicating and collaborating with different teams, such as R&D, manufacturing, product, etc., to maintain document/change management and data systems and ensure regulatory compliance with applicable standards. Responsibilities will include but are not limited to:

• Acting as a subject matter expert and working cross-functionally with our various teams
• Leading the CAPAs and supporting additional CAPA owners for timely completion, adequate root cause analysis, and deploying necessary corrective and preventive actions
• Serving as the nonconformance coordinator, ensuring timely completion and compliance for preclinical, manufacturing, clinical, and process NCRs
• Building KPIs and trend data at a regular cadence as well as making data-driven decisions to reduce the occurrence of defects/NCRs across the company
• Owning document change control and document reviews, facilitating procedure updates with process owners, and improving the existing design and automating the process
• Creating a data storage system, keeping it up to date and organized, and performing regular data storage and access audits
• Leveraging operational experience to meet quality and regulatory goals and defining processes within a Quality System
• Drafting SOPs and Work Instructions and establishing training processes as applicable
• Supporting back room & front room audits

Required Qualifications: 

• Bachelor of Science in Engineering or a related field
• 1-2 years of experience in a medical device industry
• Experience and knowledge of ISO 13485 and 21 CFR 820 requirements
• Problem-solving mindset
• Strong written and oral communication skills
• High attention to detail
• Basic understanding of statistical tools and analysis of trend data

Preferred Qualifications: 

• Experience owning and completing multiple CAPAs
• Audit Experience
• Experience designing parts of Quality Management Systems per 21 CFR 820