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Product Release Associate

Own the product release documentation process for medical device products
Mexicali, Baja California, Mexico
Mid-Level
18 hours agoBe an early applicant
Intuitive

Intuitive

Develops robotic-assisted surgical systems that enhance minimally invasive procedures through advanced instrumentation, vision, and digital technologies.
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Product Release Associate

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, 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
  • 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.
  • 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.

    • Qualifications

    Required Skills and Experience

    • Typically requires a minimum of 2 - 4 years of related experience in Product Quality role within a medical device company (Preferred).
    • Good verbal and written communication skills in English and Spanish.
    • 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 Bachelor's 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

    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 discriminaci贸n y acoso, independientemente de su raza, sexo, condici贸n de embarazo, orientaci贸n sexual, identidad de g茅nero, origen nacional, color, edad, religi贸n, condici贸n de veterano protegido o de discapacidad, informaci贸n gen茅tica o cualquier otra condici贸n protegida por las leyes federales, estatales o locales aplicables.

    Aviso sobre los Controles de Exportaci贸n de EE. UU.: De acuerdo con las Regulaciones de Administraci贸n de Exportaciones de EE. UU. (15 CFR 搂743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportaci贸n de EE. UU. para candidatos que sean nacionales de pa铆ses actualmente bajo embargo o sanciones.

    Este puesto puede cubrirse con un nivel de puesto diferente al indicado aqu铆, seg煤n las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensaci贸n se basar谩 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 legislaci贸n aplicable.

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    Product Release Associate
    Mexicali, Baja California, Mexico
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    About Intuitive
    Develops robotic-assisted surgical systems that enhance minimally invasive procedures through advanced instrumentation, vision, and digital technologies.