Product Release Associate

Descripción y detalle de las actividades

The Product Release Associate will work with multidisciplinary teams dedicated within Manufacturing, FQI, Planning and Engineering to assure compliance to of finished product quality system requirements, with the purpose to identify discrepancies related to traceability on the Device History Record, Rework of non-conforming products, ECO and Deviation implementation, Shipments of products to the sterilizer and help with the resolution of such discrepancies in order to authorize release of product to customers. Roles & Responsibilities: ·       Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements. ·       Releases ISI products, including Instruments and Accessories for distribution according to the stablished procedures. ·       Reviews and approves shipments of Single Use Devices to the sterilization process with the sterilizer contractor. ·       Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system. ·       Works collaboratively with internal and external customers to resolve non-conformances on a timely manner. ·       Escalates areas of concern to the Quality Assurance department and direct management. ·       Performs all work according to Quality standards as set by the Quality Assurance department and direct management. ·       Performs all work according to production, planning and logistics schedule, including working overtime as required. ·       Escalating to the Quality Assurance department and direct management all Quality issues that could impact patient safety, surgical efficacy or traceability. ·       Compliance with company department and standard operation procedures. Supports internal and external audits as required