Quality Engineer I

**_MAIN PURPOSE OF ROLE_**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.