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Change Control Specialist

Req ID: J2283739

  • Ubicación
    Torres, Chihuahua, Mexico
  • Categoría Ingenieria de Manufactura
  • Publicado miércoles, 1 de septiembre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

Coordinates the activities associated with the product design change control process, responsible for maintaining a change tracker as reference for the Change Review Board to understand the number of changes, the track and stage in process for each product.

This position updates and publishes the subject matter expert list at least quarterly


  • Plan, execute, and track Enterprise Change Requests and Enterprise Change Plans.

  • Reviews Change Request Forms (CRF)/ Enterprise Change Requests (ECR) and Enterprise Change Plans (ECP) for completeness and accuracy of data and information.  Assigns CRF/ECR tracking number.

  • Provides process information and data to Design Change Leader (DCL), Subject Matter Experts (SME’s) and Change Review Board (CRB).

  • Categorizes each DCRF and forwards to Subject Matter Experts for Review and Input.

  • Schedules and sets the agenda for CRB meetings.

  • Manages the “to be submitted” and “approved/rejected” CRF/ECR and ECP’s

  • Organize approved changes to the product design, manufacturing processes, and related documents for implementation per release schedule.

  • Distribute Design Change Implementation reports to management as requested.

  • Provide summary of change project information (change tracker) to the Change Control Board.

  • Design and recommend improvements to team processes, procedures and tools.

  • Responsible for communicating business related issues or opportunities to next management level

  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

  • Performs other duties assigned as needed


• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Report to Quality System Manager


  • Proven ability to plan, organize, and execute multiple changes at one time

  • Proven ability to prioritize changes of varying complexity based on impact to business and deadlines.

  • Effective at facilitating web meetings

  • Knowledge/understanding in the following areas is preferred:

    • Product Development and Life Cycle Management

    • Product Configuration Management

    • Project Management Methodologies

    • Business Systems Interrelationships

    • Product processes as they relate to manufacturing sites, system hierarchy and control/traceability requirements.

    • FDA & ISO Regulations

  • Ability to collect input and implement business process improvements with the collaboration of the design change process owner.

  • Proficient at scheduling meetings, publishing agendas, and managing attendance through tracking and follow up

  • Productive conflict resolution skills. Comfortable expressing and synthesizing contrary thoughts/opinions in an effort to arrive at the best solution to a challenge.

  • Capable of reviewing document inputs for thoroughness and consistency

  • Knowledge of document and data control systems.

  • Ability to train and mentor others.

  • PC literate: Includes word processing, spreadsheets, flowcharting, presentations and database management, including the management of SharePoint sites for storage and retrieval of data.

  • An understanding of applications associated with document control, data control and control of records.

  • Fluency with Microsoft Excel, Word, and Outlook Calendar Management


  • 6 to 8 years of experience or an equivalent combination of education / Experience

  • University/Bachelors Degree or Equivalent

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