Job Description

The Opportunity

This position is based in Querétaro within our Electrophysiology (EP) division, where we are advancing the treatment of heart disease through innovative medical technologies for atrial fibrillation, enabling people to restore their health and move forward with their lives.

What You’ll Do

This role is key to ensuring the plant’s regulatory compliance across various areas of the Quality Management System by generating and disseminating information related to quality assurance and system performance. You will contribute by conducting quality system assessments and reporting results to management.

Main Responsibilities

  • Monitor the closure of local CAPA actions and support the local implementation of global CAPA actions.
  • Develop the plant’s Quality Management System metrics: prepare and issue periodic reports to management on CAPA, NCMR, MA’s, ICS, document errors, training, and other quality system metrics.
  • Prepare plant quality data for the monthly divisional presentation.
  • Coordinate the monthly QDR meeting and the quarterly QMR meeting. Prepare the QMR presentation, review the QDR presentation, follow up on resulting actions, and submit official minutes for approval in Windchill.
  • Support the coordination of audits/inspections and participate during audits as required.
  • Ensure compliance with applicable industry regulations and requirements (FDA, ISO, MDD, among others), company policies, and Abbott procedures.
  • Provide guidance and support to internal clients in preparing QDR metrics, reviewing slides from each area, and giving feedback.
  • Communicate any regulatory changes applicable to the plant as informed by the division.

    • Required Qualifications

    Strict application of regulations and internal procedures, ensuring accuracy in reports and presentations.

    Ability to write, communicate, and collaborate effectively with global teams, both written and spoken.

    Thorough review of metrics, CAPAs, and presentations to avoid inconsistencies.

    Lead meetings with stakeholders, follow up on agreements, and maintain clear interaction across all areas.

    Ability to coordinate external dependencies and meet objectives on time.

    Preferred Qualifications

  • Customer service skills
  • Experience with Quality Management Systems

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