Quality Assurance

ExtremityCare San Antonio, TX Quality Assurance Full Time Quality Assurance Manager Non Exempt Purpose: The Quality Assurance Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements. Duties & Responsibilities: Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements. Sort and segregate acceptable and unacceptable HCT/P products. Prepare shipping documents and packages in accordance with standard operating procedures based on order requests. Communicate and escalate inspection or quality control issues to Management/Quality Assurance as necessary. Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections. Assist with reviewing HCT/P donor records in accordance with standard operating procedures and regulatory requirements. Assist in routing, editing, and finalizing controlled documents, ensuring consistency and compliance to formatting and template requirements. Initiate, review, and investigate quality events. Support and/or perform internal and external audits. File and maintain records in accordance with standard operating procedures. Maintain working knowledge of regulatory requirements. Perform other related duties as assigned. Skills & Abilities: Excellent attention to detail and organization skills Self-motivated Ability to work in a fast-paced environment. Effective verbal and written communication skills. Education & Experience: Associate degree (or 60 hours from an accredited college or university) in a biological science or related field required. Bachelor`s degree in a biological science or related field preferred. 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices preferred.