LATAM CAPA and Field Action Coordinator
Boston Scientific
Bogota, Colombia
hace 3 días

Purpose

  • The purpose of this role is to provide Quality expertise to support to the local / region / international business objectives as well as provide guidance to employees to facilitate continuous quality improvement.
  • This role ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.

    Responsibilities

  • The primary responsibility of the position will be to ensure that the corrective and preventive action process is executed in compliance with current processes.
  • In turn, it will exercise the role of CAPA mentor, providing the countries of the LATAM region with the necessary problem solving tools.

    It is also the link between the Field action global team and the LATAM countries, providing input in the preparation stage of the Field Actions, and giving support to the countries on related issues that require a different approach.

    Finally, it will be the document owner of some regional procedures and will support Quality System Management processes.

  • Maintains, advises and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site.
  • Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory / compliance oriented initiatives.
  • Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement.
  • May verify ulterior implementation of suggested solutions.

  • Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior.
  • Frequently interacts with and represents the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.
  • g. Complaint reporting, Field Action execution, etc). May also interact with national regulatory authorities.

    Job Scope and Leveling Guidelines

  • Knowledge : A developing professional. Working knowledge and application of business and technical concepts, procedures and practices.
  • General knowledge of industry practices, techniques, and standards. General understanding of business unit / group function.

    Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

  • Problem Solving : Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors.
  • Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

  • Planning and Organization : Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Discretion / Latitude; Supervision Received; Decision Making : Works under general direction regarding the progress of projects and special assignments.
  • May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.

  • Business Relationships and Project Management : Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks.
  • May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

  • Impact : Contributes to the completion of departmental proje
  • What we are looking for :

  • Graduated from the careers of Industrial Engineering, Bioengineering, Pharmacy, Biochemistry. Professional experience : at least 2 years of experience in Quality Assurance, preferably in the pharmaceutical or medical device industries.
  • Management of the Office package and digital tools for managing CAPAs. Fluent level of English, at leat B2

    Although this position is posted in Argentina, it can be hired in any of the following countries : Brazil, Colombia, Costa Rica, Chile, Mexico, Peru, Puerto Rico

    Requisition ID : 483051

    As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life.

    Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

    Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

    So, choosing a career with Boston Scientific (NYSE : BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

    Reportar esta oferta
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", doy mi consentimiento para que neuvoo procese mis datos de conformidad con lo establecido en su Política de privacidad . Puedo darme de baja o retirar mi autorización en cualquier momento.
    Continuar
    Formulario de postulación