Quality Engineer lll

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.

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.

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 III, 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 support/owns 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 of Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

• →Conduct technical and statistical investigations concerning optimization and compliance to specification.
• →Conduct NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing process.
• →Support/owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) with minimum mentorship from higher level engineering.
• →Supports activities during preparation and execution of audits (External / Internal).
• →Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering.
• →Perform supervisor activities to Quality Technicians, if required.

• Bachelor´s Degree in STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control)
• 2-4 years of experience in Quality or Engineering positions.
• At least 2 years of experience in  quality  or manufacturing engineering roles.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledge of statistical/data analysis and report writing experience.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledge of statistical/data analysis and report writing experience.
• 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.
• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• Knowledge on product and process qualification and validation.
• Intermediate command of English / Required
• Capable of maintain fluent oral communication face to face or by conference.
• Shift B

• Experience with SAP.
• ASQ CQE / Six Sigma or similar certification.
• Participation or leading multi-department project teams.
• Experience in supervision role.

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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.

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In specific locations, the pay range may vary from the range posted.