The Opportunity This position works out of our Costa Rica – Alajuela location in the Electrophysiology Division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Quality Engineer I, you will be responsible to work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR's, MA's, Yield, Cost Reduction projects, etc.) and owns/lead process/product validation activities. Work closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)What You'll Do Verify company's adherence to the established Quality System and GMP/ISO standards.Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)Required QualificationsBachelor´s Degree Engineering.0-3 years of experience.Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).Knowledge of statistical, data analysis.Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.Knowledge with control of nonconforming material, corrective and preventive actions.Knowledge of FDA, GMP, and ISO 13485 regulations.Intermediate Command of English.Shift BPreferred QualificationsPrior medical device industry experience.Previous Quality Engineering experience.Experience with SAP ERP System.Knowledge on product and process qualification and validation.1 - 2 years of experience in Quality or Engineering positions.
