Post Market Quality Engineer 1 CR

hace 2 semanas

Alajuela, Alajuela, Costa Rica Hologic A tiempo completo $40.000 - $80.000 al año
  • Education / Educación:

  • University Bachelor's degree in engineering, or related career.

  • Experience / Experiencia:

  • No experience required.

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

  • FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
  • Equipment qualification.
  • Laboratory good practices.
  • Test method and procedure development

  • 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, Internet, Minitab, Oracle, Agile and H1.

  • Qualifications / Calificaciones:

  • Drive for Results
  • Planning
  • Organizational Agility
  • Listening
  • Decision making
  • Problem Solving

  • Communication

  • Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

  • Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE).
  • Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
  • Testing of returned units from reported complaints.
  • Ensure complaint investigation procedures are best in class and aligned with the requirements.
  • Close complaints in a timely manner.
  • Ensure KPIs are met in accordance with the established goals.
  • Review and approve complaint investigations in the QMS, as required.
  • Provide input to the organization regarding the information gathered from complaint investigations.
  • Support preparation of budget forecasts and ensure compliance with the approved budget.
  • Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
  • Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance's requirements.
  • Support Product Transfers.
  • Participate, support and/or lead PMS projects
  • Support and promote the implementation of EHS programs to ensure staff safety and environmental health.
  • Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor.
  • Coordinate services with suppliers and availability of the required supplies in house. (as applicable).
  • Coordinate and ensure that required payments to vendors are performed on time.
  • Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
  • Support other facilities and OEMs/CMs, as required.
  • Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required.
  • Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.

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