Records and Change Control Manager

hace 2 semanas

Mexicali, Baja California, México Intuitive Surgical A tiempo completo
Company DescriptionDescripción 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

The Records and Change Control manager is responsible for managing globally all aspects of records and change control for a medical device organization. This function coordinates and ensures alignment between corporate and other sites where quality system records are generated and maintained.

Manage Change Control process for Intuitive Surgical. Responsible for professional development and training of the broader change control community and staff. Evolve change control practices while ensuring compliance to applicable standards and regulations (i.e., ISO 13485, 21 CFR820, 21CFR11). Improve and influence cross-functional change control processes. Ensure compliant change control processes are implemented and aligned globally.

Essential Job Duties

Records Controls Function

  • Creates centralized global responsibility for records management process(es)
    • Owns the records process.
    • Assures standardized processes across sites.
    • Provide training about applicable global standards and regulations
  • Maintains oversight of record lifecycle
    • Addresses overlapping record responsibilities (IT, Legal, Privacy, etc)
    • Identifies and tracks essential process metrics
    • Ensures procedure alignment with standards and regulations
    • Proactively identifies process gaps and recommends solutions
  • Provides guidance to record process customers throughout record process.
    • Works with records owners to streamline processes, ensuring regional requirements are implemented and align with international and company requirements.
    • Assists process creators with defining process record outputs and storage locations.
    • Creates and maintains compliant templates for record creation.
    • Assists in retrieving records upon user or auditor request.
    • Reviews and stores records from external sources
    • Coordinates record disposal activities on defined schedule
    • storage locations to ensure that records inventory is accurate.
    • Maintains database of GxP systems
  • Provides continuous GxP training
    • Proactively identifies GxP training gaps
    • Addresses training needs both routinely and as needed
    • Supports process metric goals

Manage Change Control Function

  • Facilitates change control board review of impact of changes and review and approval of changes
  • Ensures changes include appropriate assessment, impact, review, approval, and implementation of all changes requested
  • Proactively and effectively communicates changes to impacted functions and teams to ensure timely change processing
  • Provides guidance to team leaders and approvers. Reviews all changes to ensure requirements are complete before submission to the Change Control Review Board
  • Collaborates with different department managers to ensure integrity of changes and process improvements
  • Works with Sr Manager of Change Control to ensure a seamless flow between Change Control and Document Control
  • Participates in the development and/or revision of Quality system SOPs relating to Change Control. Prepares and distributes monthly and quarterly metrics reports (written and graphic) to plant management regarding the status of changes and their sources and participates in the development of quality performance measures.
  • Supports the Quality Systems Department with internal and external audit processes.
Qualifications

Required Skills and Experience

  • 10+ years' experience in Quality or Document Control/Change Control, preferably at medical device company
  • 5 years' experience with managing Agile (ACCS) System, Veeva and ERPs systems and implementation systems improvements.
  • 10+ years of previous experience working in Change Control within a Quality Management System in the Medical device or pharmaceutical industry.
  • Experience in establishing and maintaining a change control process including developing change implementation plans, determining change control requirements, and ensuring all changes are implemented in a manner to control risk to the organization
  • Experience with an electronic documentation system – Agile preferred
  • Demonstrated knowledge of Risk Programs Demonstrated ability to influence, organize and motivate cross-functional teams at all levels in the organization to meet quality and compliance goals.
  • Ability to analyze complex problems and apply practical solutions.
  • Competent using Microsoft Word, Microsoft Excel, and Microsoft Outlook.
  • Experience in the application of problems solving tools.
  • Ability to work with multiple departments and locations to resolve issues
  • Fluent in English. Well-developed written and verbal communication skill
  • Ability to communicate clearly and concisely within a diverse environment.
  • Ability to work independently with minimal supervision. Hand on.
  • Detail oriented and organized. Able to work in multitask.
  • Excellent teamwork and collaboration skills.

Required Education and Training

  • Bachelor's Degree in a Technical or Science field -Preferable or 15 years+ experience equivalent in a medical technical function.
  • ISO 13485, 21 CFR820, 21CFR11 Training Certification
  • Familiar with other regional and international regulations
  • Desing Controls and Risk Management Training is a plus.
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: 25% of the time

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