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 STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control).
• 1 - 2 years’ experience in Quality or Engineering positions.
• At least 1 year 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.
• 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 validation
• Intermediate Commands of English: Capable of maintaining fluent oral and writing communication face to face or by conference, and/or mail.

PREFERRED QUALIFICATIONS

• Prior medical device industry experience.
• Previous Quality Engineering experience.
• Experience with SAP ERP System.
• Knowledge on product and process qualification and validation.

• 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 activities
• Conducting 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 mentorship from higher level engineering.