Product Release Specialist

Primary Function of Position

The Product Release Specialist 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, requirements 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.

Essential Job Duties

• Reviews and approves manufacturing Device History Records for all assembly levels, ensuring compliance with device master records and other Quality System requirements.
• Performs the following process as necessary:
  • Review and release of ISI products, including Instruments, Accessories and Endoscopes (Refurbish) for distribution according to the stablished procedures.
  • Review and approve any non-conformances documented on the Device History Record.
    • Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
    • Handling, storage and monitor of non-conforming inventory in the quarantine areas, performing cycle counts and delivering products to manufacturing operations for sorting or rework.
    • Processing of dispositioned material - scrapping of parts from NCRs
    • Coordinates transfers of non-conforming material between plants.
  • Review and approve of shipments of Single Use Devices to the sterilization process with the sterilization contractors.
  • Review, approve and release of sterile products manufactured by Intuitive or from a Contract Manufacturer.
• Works collaboratively with cross functional teams and external customers to resolve non-conformances on a timely manner.
• Performs inventory transactions and ensures that released products are transacted in a timely manner to maintain inventory accuracy for department inventory locations.
• 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.
• Leads and participates in department process improvement projects or other activities as directed by management.
• Maintains a strong understanding of QMS procedures for directly adjacent departments (i.e., Manufacturing, Planning, FQI, Logistics, Engineering).
• Supports internal and external audits as required.
• Solve concerns of his colleagues and members of other departments about their procedures.
• Provides support to Manufacturing Engineers during PPQ’s.
• Acts as a mentor for personnel in training in case of absence of the Product Release leader.
• Ensuring successful, on-time completion of department projects; communication constraints to direct management when successful project completion is a risk.
• Publishes Quality and operational metrics to direct management as required.