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