Quality Assurance Specialist

hace 3 semanas


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo
About the Role

At Abbott Laboratories, we are searching for a skilled Quality Engineer IV to join our team. This position plays a critical role in ensuring the quality of our products and processes.

As a Quality Engineer IV, you will be responsible for working closely with Manufacturing and Engineering teams to sustain activities and ensure compliance with quality system requirements. You will also be responsible for owning and leading process/product validation activities, as well as working with Research and Development and Regulatory Affairs personnel to obtain support on sustaining activities and during new product introduction.

  • Support technical and statistical investigations concerning optimization and compliance to specification.
  • Own measuring process capability, process controls, and process validation/efforts.
  • Conduct NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
Requirements
  • Bachelor's Degree in STEM field (Science, Technology, Engineering, or Math) or equivalent experience in medical devices or pharmaceutical quality control.
  • 4-6 years of experience in Quality or Engineering positions.
  • At least 4 years of experience in Quality or Manufacturing Engineering positions.
  • 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.


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