Quality Assurance Specialist at Precision Neuroscience

Addison, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

0.0

Posted On

16 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

eQMS Administration, Document Control, CAPA, Incoming Quality Assurance, ISO 13485, FDA 21 CFR 820, Medical Device Manufacturing, Inventory Tracking, Internal Auditing, Supplier Qualification, Complaint Handling, NCR Management

Industry

Medical Equipment Manufacturing

Description

ABOUT PRECISION NEUROSCIENCE 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. Key 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. Skills, Knowledge and Expertise Required: * 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. Preferred: * 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.Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law. The actual base salary offered is determined by a number of variables, including, as appropriate, the applicant's qualifications for the position, years of relevant experience, distinctive skills, level of education attained, certifications or other professional licenses held, and the location of residence and/or place of employment. We prioritize candidate security. Please be aware that job offers will only come from emails ending with @precisionneuro.io [http://precisionneuro.io] For roles based in Massachusetts: it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Precision Neuroscience does not accept unsolicited resumes or candidate profiles from recruitment agencies, staffing firms, or third-party recruiters. Any resumes submitted without a prior written agreement and an authorized job order will be considered the property of Precision Neuroscience, and no fee will be owed in the event a candidate is hired. All qualified candidates should apply directly through our careers page.

Responsibilities

The role involves administering the eQMS, managing document control, and tracking inventory for R&D and clinical product builds. The specialist will also support quality system processes including CAPAs, internal audits, and incoming quality inspections.