Quality Assurance Specialist jobs in United States
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Neuralink · 14 hours ago

Quality Assurance Specialist

Neuralink is creating devices that enable a bi-directional interface with the brain. The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure compliance with relevant regulatory standards and will be responsible for maintaining protocols, performing inspections, and communicating QA findings to management.

BiotechnologyMedicalNeuroscienceRobotics
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Maintaining copies of all approved protocols
Maintaining a master schedule of all GLP- regulated studies
Performing pre-qualification inspections of the testing facilities as needed
Providing general periodic status reports to management and the study director pertaining to facility, quality control, and preclinical study compliance
Inspecting and auditing at intervals adequate to ensure the integrity of the data and verify applicable compliance
Communicating the findings of all QA inspections to appropriate management via signed inspection reports
Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation
Reviewing study protocols to ensure compliance before study initiation
Verifying that final study reports accurately reflect the raw data, protocol, methods, and SOPs used in conducting the GLP study
Preparing a Quality Assurance Statement to be included in final reports
Writing and reviewing Quality Assurance SOPs
Reviewing equipment, software, and other computer-system validations and qualifications when applicable
Inspecting critical vendors
Ensuring personnel training records are maintained by staff
Conduct GLP training for staff as needed, such as for new hires or when training certifications have expired
Serving as a point of contact and assisting with FDA inspections

Qualification

FDA regulationsQuality Assurance SOPsGLP complianceGxP auditingGoogle Docs proficiencyCommunication skillsOrganization skillsAttention to detail

Required

Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline
Minimum of 1 year of experience in a medical device or life sciences organization
Minimum of 1 year of experience within a regulatory environment
Minimum of 1 year of experience with FDA regulations and requirements
Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
Ability to travel to/from work in multi-state locations

Preferred

Experience auditing multiple GxP processes
Experience with auditing quality control testing
Strong understanding of the scientific method and engineering-first principles
Understanding within the fields of microbiology and chemistry
Excellent organization and communication skills
Keen eye for detail

Benefits

Excellent medical, dental, and vision insurance through a PPO plan
Paid holidays
Commuter benefits
Meals provided
Equity (RSUs) •Temporary Employees & Interns excluded
401(k) plan •Interns initially excluded until they work 1,000 hours
Parental leave •Temporary Employees & Interns excluded
Flexible time off •Temporary Employees & Interns excluded

Company

Neuralink

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Neuralink is a neurotechnology company that focuses on developing brain-computer interfaces designed to treat neurological disorders.

H1B Sponsorship

Neuralink has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (5)
2021 (7)
2020 (6)

Funding

Current Stage
Late Stage
Total Funding
$1.34B
Key Investors
CoreNest CapitalFounders FundVy Capital
2025-07-07Series Unknown
2025-06-17Secondary Market
2025-05-27Series E· $649M

Leadership Team

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Dongjin Seo
Co-Founder, President & COO
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Shivon Zilis
Director of Operations and Special Projects
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Company data provided by crunchbase