Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to help establish, implement, and maintain quality processes and policies at Precision Neuroscience. In this role you will collaborate with physicians, neuroscientists, and engineers to develop a 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 U.S. and are not legally authorized to work in the U.S. Key Responsibilities Administer and maintain an eQMS, including Document Control, Training Management, CAPAs, NCs, and other quality records, with guidance. Administer and maintain the purchasing process for purchase orders that fall under the QMS. Administer and maintain inventory and quarantined materials within Precision’s QMS under guidance from Quality Engineers. Create, manage, and assist assembly build requests for all R&D and clinical product builds. Support the quality team in executing reworks, generating labeling, 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 higher in a relevant scientific discipline. Minimum of 1–3 years of medical device industry experience (internship experience acceptable). 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 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. 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. #J-18808-Ljbffr