**About Abbott**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:- Career development with an international company where you can grow the career you dream of.- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**The Opportunity**This position works out of our Costa Rica - Alajuela location in the Structural Heart Division. In Abbott's our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.As the Sr. Quality Engineer, 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. Own Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).Responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support. Work with minimum supervision and assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.**What You'll Do**- Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship to lower level engineering positions.- Owner of measuring process capability, process controls, and process validation / efforts.- Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.- Support and lead Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)**Required Qualifications**- Bachelor's degree Engineering.- 5-7 years of experience in Quality Engineering positions.- At least 5 years of experience, with preferably 3+ years in a quality engineering roles.- Knowledge of statistical/data analysis and report writing experience.- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.- Experience in process improvement tools such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).- Detailed knowledge of FDA, GMP, and ISO 13485.- Experience on product and process qualification and validation.- Project management experience, participating or leading multi departmental project teams.- Experience on External and Internal audits.- Provide mentorship to lower-level engineering positions on Technical Writing- Advance Command of English / Required / Fluent oral and writing communication including technical writing**Preferred Qualifications**- Experience with SAP.- ASQ CQE / Six Sigma Blackbelt or similar certification.- Participation or leading multi-departmental project teams.- Experience in supervision role.- Master's Degree on position related field.Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
