Product Release Associate

Job Description

Primary Function of Position:
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.
• 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.

Qualifications

Skills, Experience, Education, & Training:

• High School, Technical Diploma or Bachelor’s degree.
• 6 months to 1 year relevant experience in QA/QC role within a medical device company (Preferred).
• Ability to read English, read and comprehend instructions, write short correspondences and memos, complete quality documentation in English and Spanish, effectively present information in one on one and small group situations involving employees, supervisors or engineers.
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements.
• Demonstrated ability to be a quick learner and understand complex products and processes.
• Exceptional analytical, problem-solving, and root-cause analysis skills.
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions and when dealing with others.
• Demonstrated ability to work independently and with minimal supervision, multi-task, and handle tasks with competing priorities effectively.
• Very strong computer skills and experience with Windows operating system and Microsoft Office.
• Ability to travel domestically and internationally.
• Availability to work on different Shifts as needed.
• Demonstrated interest in Medical devices, anatomy, surgery and the medical field.
• Experience with Agile/ACCS and SAP or other electronic documentation systems.
• English Level B1 – B2.
• Ability to move heavy material (Pallets) with a Pallet Jack on a frequent basis (if required).
• Walking and repetitive physical motion like squatting, bending and lifting (if required).

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones.

Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación).
Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines.

Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable.