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Post Market Quality Specialist 2 CR

Hologic
1 día hace
A tiempo completo
En el sitio
Alajuela, Costa Rica
Description
  • Education / Educación: 

  • University Bachelor's degree in Engineering or similar.

     

  • Experience / Experiencia: 

  • 2 years on position of similar responsibility, decision making and problems resolution. 

     

  • 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 and H1.

 

  • Qualifications / Cualificaciones: 
  • Drive for Results
  • Planning
  • Organizational Agility
  • Listening
  • Decision making 
  • Problem Solving
  • Communication

 

  • Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
  • Prepare and present Post Market Surveillance Review Board meetings for the products under her/his responsibility. 
  • Ensure PMS RB records are released in the PLM system on a timely manner. 
  • Facilitator of low to moderate complexity investigations and conduct timely and insightful response to investigations. Work on moderate problems where analysis of situation or data requires a review of a variety of factors. 
  • Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
  • Identify unacceptable trends and ensure application of suitable corrective actions to reduce defects / meet quality objectives (when required).
  • Facilitate investigations for emerging issues. 
  • Complete Post Market Surveillance documentation as PMS Plans, PMS Reports, Periodic Safety Update Reports (PSURs), Canadian Summary Reports and similar documentation. 
  •  Provide complaint data for clinical documents such as Post Market Clinical Follow up (PMCF) and Clinical Evaluation documents. 
  • Responsible for planning PMS Reports, PSUR and Canadian Summary Reports cadence. 
  • Maintain data mining tools to monitor trends. Define Control and / or Action Limits to detect emerging field issues.
  • Participate in product transfers. 
  • Support Health Risk Assessments (HRA) and Health Hazard Evaluation (HHE) processes.
  • Lead and facilitate cross functional meetings, as needed.
  • Provide guidance to the PMS Team on the investigation process of her/his products.
  • Maintain, improve, and simplify procedures, processes, and methods.
  • Participate in Internal and External Audits/Inspection and Assessments.

  • Make decisions following a risk-based approach, implement tools such as FMEA, Fault Tree Analysis (FTA) and risk evaluation.