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Document Control Specialist 3

  • Mexicali, B.C., Mexico
  • Not Remote
  • Engineering
  • JOB7283

Company Description

Descripción de la empresa

En Intuitive, estamos unidos detrás de nuestra misión: creemos que la atención mínimamente invasiva es la atención que mejora la vida. Mediante la inventiva y la tecnología inteligente, ampliamos el potencial de los médicos para curar sin limitaciones.

Como pioneros y líderes del mercado en cirugía robótica, nos esforzamos por fomentar un equipo inclusivo y diverso, comprometido con marcar la diferencia. Durante más de 25 años, hemos trabajado con hospitales y equipos de atención de todo el mundo para ayudar a resolver algunos de los desafíos más difíciles de la atención médica y avanzar en lo que es posible.

Intuitive se ha construido gracias a los esfuerzos de grandes personas de diversos orígenes. Creemos que las grandes ideas pueden provenir de cualquier lugar: nos esforzamos por fomentar una cultura inclusiva basada en la diversidad de pensamientos y en el respeto mutuo. Lideramos con inclusión y capacitamos a los miembros de nuestro equipo para que trabajen de la mejor manera y manifiesten su auténtica personalidad.

Las personas apasionadas que quieren marcar la diferencia impulsan nuestra cultura: los miembros de nuestro equipo se basan en la integridad, tienen una sólida capacidad para aprender, la energía para hacer las cosas, y aportan experiencias diversas del mundo real para ayudarnos a pensar de nuevas maneras. Invertimos activamente en los miembros de nuestro equipo para apoyar su crecimiento a largo plazo y así poder continuar avanzando en nuestra misión y alcanzar su máximo potencial.

Únase a un equipo comprometido a dar grandes pasos hacia delante para una comunidad global de profesionales de atención médica y sus pacientes. Juntos, avancemos en el mundo de la atención mínimamente invasiva.

Job Description

Primary Function of Position:
The Document Control Specialist 3 is responsible for assisting the Document Control lead and manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs). This role requires sedentary and repetitive working conditions.

 

Roles & Responsibilities:

  • Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes  accurately and in a timely manner while ensuring that they meet the department goals and objectives
  • Audit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is released
  • Provide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.
  • Provide Agile and change procedure training support as needed to co-workers within and outside Document Control
  • Promptly respond to questions and issues raised by Originators and Approvers
  • Work with ECO Coordinator to select changes for CCB meetings based on production impact
  • Represent Document Control at CCB meetings
  • Work with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issues
  • Provide continuous improvement of Document Control processes/procedures in accordance with department and company goals
  • Familiarity with Design History requirements and documents
  • Experience with and, clear  understanding of the Quality System Regulations and ISO 13485 requirements 
  • Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals
  • Provide change control training (processes and system) to users
  • Maintain change control training materials up to date
  • Create and maintain change control metrics and reports

Qualifications

Skills, Experience, Education, & Training:

    • Education
      • College degree 
    • Experience
      • 5+ years’ experience working in Document Control in a Regulatory or Quality organization with a minimum of 3 years at medical device company
      •  Experience processing changes using an electronic documentation system
      • Proficient using Word and Excel applications, and Windows operating system
      • Experience using Agile
    • Skills
      • Must be able to work effectively in a fast paced, team oriented environment
      • Ability to work independently with minimal supervision
      • Demonstrated ability with database applications. Proficient using Word and Excel application, and Windows operating system
      • Demonstrated cross-functional teamwork skills
      • Self-starting, detailed oriented, and ability to focus on task at hand
      • Ability to work independently with multiple departments to resolve Document Control issues
      • Well-developed English written and verbal communication skills
    • Training

 

      • Product Lifecycle Management (PLM) Processes and System
      • Change Control Management
      • Quality System Regulations
      • ISO 13485 2016

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.

Shift: Day
Travel: 10% of the time

The Future is Intuitive

At Intuitive, we envision a future where care is more connected, customized, and intelligent—so the question won’t just be how long we live, but how well.

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