Quality Engineer IV

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. 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 Quality Engineer IV, 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

• Support technical and statistical investigations concerning optimization and compliance to specification. Also, provide support 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 Major Quality System investigations (i.e., CAPAs, HHEs, StopShip, etc.)
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required Qualifications

• Bachelor´s Degree STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control).
• 4-6 years of experience in Quality or Engineering positions.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• 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 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.
• Project management experience, participating or leading multidepartment project teams.
• Advance command of English.
• Fluent oral and writing communication including technical writing.
• SHIFT Admin

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.