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 PPQs.
• 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.

Qualifications :

Required Skills and Experience

• Typically requires a minimum of 4 - 6 years of related experience in Product Quality role within a medical device company (Preferred).
• Typically requires a minimum 6 months of relevant experience as Product Release Associate.
• Good verbal and written communication skills in English and Spanish.
  • Ability to 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.
• 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.
• Ability to work in a team environment and with cross-functional teams.
• Very strong computer skills and experience with Windows operating system and Microsoft Office.
• Availability to work on different Shifts as needed.

Required Education and Training

• High School Technical Diploma or Bachelors degree.

Working Conditions

• 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).
• Ability to work in a controlled environment room (i.e. clean room)
• Personal Protection Equipment: Safety Shoes and Safety Glasses

Preferred Skills and Experience

• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to ISO13485 and U.S. FDA 21CFR820.
• Demonstrated ability to be a quick learner and understand complex products and processes.
• Excellent analytical problem-solving and root-cause analysis skills.
• Ability to travel domestically and internationally.
• Demonstrated interest in Medical devices anatomy surgery and the medical field.
• Excellent computer experience on ERP systems (preferably SAP/Agile or other Electronic Documentation Systems).
• High motivation and enthusiasm as well as a pronounced awareness of quality order and cleanliness.

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.

Remote Work :

No

Employment Type :

Full-time