Quality Assurance Specialist

Quality Assurance Specialist Position: Quality Assurance Specialist – Addison, TX office. This role is not remote. 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 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. Required Skills BS or higher in a relevant scientific discipline. A minimum of 1–3 years’ medical device industry experience is necessary (internship experience acceptable). Excellent interpersonal written and verbal communication skills. Preferred Skills 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 willingness to jump in wherever needed. 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. #J-18808-Ljbffr Precision Neuroscience