Post Market Quality Specialist 1 CR (Temp 12 months)

• 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