Product Release Associate

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

Requirements

• 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 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.
• Documents non-conformances through the corresponding quality notification (NCR, VR, DN) on ISI electronic documentation system.
• Handling and storage of non-conforming inventory in the quarantine areas, performing cycle counts and delivering products to manufacturing operations for sorting or rework.
• 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.

Benefits

• equal employment opportunity
• no discrimination and harassment
• fair labor standards act compliance