Quality Engineer I
abbot
Alajuela, Costa Rica
hace 3 días

MAIN PURPOSE OF ROLE

Analyze quality standards for components, materials or services.

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

MAIN RESPONSIBILITIES

  • 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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