Quality Engineer I

at  Abbott Laboratories

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.

REQUIRED QUALIFICATIONS

• Bachelor´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 B

PREFERRED QUALIFICATIONS

• Prior 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.

• 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.)