Quality Engineer I
Alajuela, Costa Rica
hace 3 días


Analyze quality standards for components, materials or services.

Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.


  • Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
  • Conduct inspection, verification and validation of components or materials used in development processes.
  • Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
  • Document quality issues and performance measures for management review.
  • May liaise with external vendors.
  • Education

  • 0-3 years of experience.
  • Bachelor Degree. Engineering : Biotechnology, Chemistry, Industrial, Electromechanical or related.
  • 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.
  • Language Proficiency
  • Intermediate Commands of English / Required
  • Shift B
  • Preferred Qualifications & Education

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