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 II, you will be responsible to work closely with Manufacturing and Engineering on manufacturing execution system (MES) 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 project activities and during new product introduction to assure compliance with product and regulatory requirements.Own 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.Completion of risk management and risk analysis including FMEA.Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.Conducts technical and statistical investigations concerning optimization and compliance to specification.Owner of measuring process capability, process controls, and process validation / efforts.Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesConducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing ProcessSupport/owns Major Quality System investigations (i.e.CAPAs, HHEs, StopShip, etc.)with mentorship from higher level engineering.Required QualificationsBachelor´s Degree STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control).Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).Knowledge of statistical/data analysis and report writing experience.Knowledge working on FDA, GMP, and ISO 13485 Regulated environments.Experience 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.Knowledge on product and process qualification and validationCapable of maintaining fluent oral and written communication face to face or by conference, and/or mail.SHIFT ADMINPreferred QualificationsPrior medical device industry experience.Previous Quality Engineering experience.Experience with SAP ERP System and manufacturing execution systems (MES)Knowledge on product and process qualification and validation.
