Education / Educación: 50% of total percentageof University Bachelor's degree in engineering, or related career.Experience / Experiencia: No experience required.Specialized Knowledge(Desirable) / Conocimiento especializado (preferible): FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947,EU MDD/MDR and any relatedISO 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 Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades: Support Operational Excellence program and initiatives.Support local and extended CSPOs, VIP projects, improvement initiatives, NPIs, producttransfers, implementation of new technologies.Control best in class metrics and quality reports related to the implemented in the Post Market Surveillance Laboratory.Innovate processes to improve efficiency and ensure compliancewith the Post Market Surveillance's requirements.Maintain, improve, and simplify procedures, processes, and methods.Support and promote the implementation of EHS programsto ensure peoplesafety and environment health.Coordinate services with suppliers and availability of the requiredsupplies in house.(as applicable).Coordinate and ensurethat required paymentsto vendors are performed on time.Ensure testing, investigations are performed in accordance with the procedures and on a timely manner.Support track and trending of complaints.Create and execute new procedures, new testing methods,validations and any other compliance requirements.Make decisions based on a risk thinking, implement tools as PFMEA,Fault Tree Analysis (FTA) and risk evaluation.Review and approvecomplaints investigations in the QMS, as required.Ensure equipment is properly calibrated and controlled with the QMS. Ensure Preventive Maintenance program is implemented as required.Provide guidance to CSPOs, inspectors, technicians, supervisors, and engineers in technical mattersrelated to Post Market Surveillance.Execute investigations such as OOTs, NCEs,CAPAs, IACAs and/or similar. Ensurethey are performed on time, in compliance with procedures and regulations.Escalate to the ClinicalSpecialists and PMS Manager in case there is any Potential AdverseEvent.Qualifications / Calificaciones: Drive for Results Planning Organizational Agility Listening Decision making Problem Solving Communication
