About this role
• 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