Quality Assurance Specialist

Precision Neuroscience•Addison, TX

8h•Onsite

About The Position

Precision Neuroscience is building a next-generation brain–computer interface (BCI) to heal and empower millions of people living with neurological conditions. Our first product, Layer 7 , is designed to help people with severe paralysis operate digital devices using only their thoughts—opening up new possibilities for daily life. Our team brings together experts in neurosurgery, AI and machine learning, microfabrication, electrical engineering, clinical science, and more. We combine deep technical rigor with a people-first mindset to turn breakthrough research into real-world medical solutions. As a Precision employee, you’ll join one of the fastest-moving and best-capitalized companies in the emerging field of brain–computer interfaces. Since our founding in 2021, we have raised more than $180 million, advanced our technology through validation, and initiated human trials with leading hospitals across the country. Our Values: We build for human impact , measuring progress by the lives our work can change. We do no harm , holding ourselves to the highest standards of safety, integrity, and responsibility. We innovate with urgency , because the stakes are high and our users can’t wait. We bring sharp minds, open ears , pairing expertise with curiosity, humility, and respect. And we lead the way , taking ownership of our work and helping to shape the future of our field. We are seeking a Quality Assurance Specialist to help establish, implement, and maintain Quality processes and policies for Precision Neuroscience. In this role you'll collaborate with physicians, neuroscientists, and software, hardware and machine learning engineers to develop the next-generation human-ready Brain-Computer Interface (BCI). This position will be based in our Addison, TX office. We are unable to consider remote workers or individuals who are not currently based in the US and are not legally authorized to work in the US.

Requirements

BS or more in a relevant scientific discipline.
A minimum of 1-3 years’ medical device industry experience is necessary (can be internship experience).
Excellent interpersonal written and verbal communication skills.

Nice To Haves

Ability to focus on and achieve scheduled milestones, including contingency planning.
Knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO standards related to medical device manufacturing.
Experience in working with Class II or III medical devices.
Strong team-working and communication skills.
A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.

Responsibilities

Administer and maintain an eQMS (including but not limited to Document Control, Training Management, CAPAs, NCs, and other quality records) with some guidance.
Administer and maintain the purchasing process for purchase orders that fall under the QMS.
Administer and maintain and track inventory and quarantined materials that are within Precision’s QMS under guidance from Quality Engineers.
Create/manage/assist assembly build requests for all R&D and clinical product builds.
Support quality team in executing reworks, generating labelling, and qualifying lower-risk suppliers and equipment.
Track clinical build inventory, including material allocation, kitting, and reconciliation across R&D and clinical product builds.
Assist with Incoming Quality Assurance (IQA) inspection activities, including receiving inspection and disposition of incoming materials and components.
Support internal and external auditing processes through notetaking and assisting the Quality Manager and Engineers in gathering required documentation.
Support quality system processes including CAPAs, internal audits, NCRs, Supplier Quality and Complaint Handling systems
Perform additional responsibilities or other functions as assigned.