Hologic, Inc.

Discussion

Post Market Quality Specialist 1 CR (Temp 12 months)

Open 19d
  • Education / Educación:

  • University bachelor’s degree in engineering or similar.

    Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):

  • FDA regulations, ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.

  • Statistics.

    Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):

  • Spanish/English (Advanced level)

    Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:

  • Microsoft Office, Minitab, Oracle, Agile

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades

  • Prepare Post Market Surveillance Review Board meetings according to business needs.
  • Escalate to his/her supervisor if a statistical signal is identified when preparing Review Boards.
  • Facilitator on low complex to moderate investigations and conduct timely and insightful response to investigations.
  • Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
  • Maintain data mining tools to monitor trends.
  • Participate in product transfers.
  • Facilitates cross functional meetings, as needed.
  • Maintain, improve, and simplify procedures, processes, and methods.
  • Participate in Internal and External Audits/Inspection and Assessments.
  • Make decisions based on risk thinking, PFMEA, Fault Tree Analysis (FTA) and risk evaluation.

  • Support other roles in the PMS organization:

    • Assess complaints and escalate potential adverse events.
    • Investigate physical returned units.

    Qualifications / Cualificaciones:

  • Drive for Results
  • Planning
  • Problem Solving
  • Communication
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