Post Market Quality Engineer 2 CR Alajuela, Costa Rica + **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