PMQ Engineer 1 CR (Temporary 12 months) Alajuela, Costa Rica + **Education / Educación:** University Bachelor's degree in engineering, or related career. + **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. + Equipment qualification. + Laboratory good practices. + Test method and procedure development + 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, Internet, Minitab, Oracle, Agile and H1. + **Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:** + Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE). + Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described. + Testing of returned units from reported complaints. + Ensure complaint investigation procedures are best in class and aligned with the requirements. + Close complaints in a timely manner. + Ensure KPIs are met in accordance with the established goals. + Review and approve complaint investigations in the QMS, as required. + Provide input to the organization regarding the information gathered from complaint investigations. + Support preparation of budget forecasts and ensure compliance with the approved budget. + Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast. + Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance’s requirements. + Support Product Transfers. + Participate, support and/or lead PMS projects + Support and promote the implementation of EHS programs to ensure staff safety and environmental health. + Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor. + Coordinate services with suppliers and availability of the required supplies in house. (as applicable). + Coordinate and ensure that required payments to vendors are performed on time. + Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation. + Support other facilities and OEMs/CMs, as required. + Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required. + Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations. + **Qualifications / Calificaciones:** + Drive for Results + Planning + Organizational Agility + Listening + Decision making + Problem Solving + Communication