Quality Engineer I
- Alajuela
- Permanente
- Tiempo completo
Analyze quality standards for components, materials or services.
**_ MAIN RESPONSIBILITIES_**
- 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.
**_ QUALIFICATIONS_**
**_ Education_**
- 0-3 years of experience.
- Bachelor Degree.
Engineering: Biotechnology, Chemistry, Industrial, Electromechanical or related.
- 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**
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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