Education / Educación:  University Bachelor's degree in Engineering or similar.

 

Experience / Experiencia:  Minimum 2 years of professional experience, with a bachelor’s degree, in positions of a similar nature. 

 

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. 

 

 

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

 

Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades: Investigate returned products (complaints related).  Facilitate, process, assess and close complaints in the Electronic Complaint Management System. Identify and escalate potential adverse events.  Support and analyze best in class metrics and quality reports related to the implemented in the Post Market Surveillance Laboratory.  Maintain, improve, and simplify procedures, processes, and methods. Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance’s requirements.  Work with Technical Service and/or Field Service to ensure appropriate required information is documented in complaint. Work on problems of moderate in scope where analysis of situation or data requires a review of a variety of factors.  Work on transfer of information for new products to the rest of the PMS team (if applicable). Participate in Internal and External Audits/Inspection and Assessments, as needed. Support risk assessments and Health Hazard Evaluation (HHE) processes. Execute and/or supervise execution of investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time and in compliance with procedures and regulations. Make decisions based on a risk thinking, PFMEA, Fault Tree Analysis (FTA) and risk evaluation. Support other facilities and OEMs/CMs, as required. Support local and extended core teams, VIP projects, improvement initiatives, NPIs, product transfers, implementation of new technologies.  Implementation of cost reduction projects that support business strategies. Operational Excellence program and related initiatives.  Support and promote the implementation of EHS programs to ensure people safety and environment health.  Act as back up of the Complaints Laboratory Supervisor when requested by the Post Market Surveillance Manager. 

 

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