Quality Engineer

Quality EngineerResponsibility:· Develop, maintain and monitor quality processes to ensure compliance to ISO and FDAregulations.· Quality representation for the development of new products and processes including evaluationof technical drawings, test methodologies, and validation to ensure compliance· Lead non-conformance investigations along with other departments to identify root cause andassure nonconforming products dispositioned properly.· Presents findings of trend review or nonconformances to team and/or management staff· Author technical reports regarding nonconformance and complaint investigations as well aseffectiveness reports for completed CAPA· Completion of risk assessment such as pFMEA to identify risks to product for determining theconcession release of material through the Material Review Board· Assist in determining quality improvements by using relevant statistical method to testingmethodologies and/or manufacturing processes and leading improvement projects for safety,quality, and productivity based on findings· Represent Quality in change control process, validation, and continuous improvement activitiesfor the Production and Quality Control departments as assigned· Analysis of Quality trends and reporting on them for management review as well as escalation ofidentified trends· Create, review and approve fixture designs and prototypes· Monitor the effectiveness of employee training required in the inspection processes· Author SOPs, test procedures, validation protocols and reports· Author engineering studies using scientific principles· Performs tasks accurately and with great attention to detail· Other duties as assigned Job Requirements:· Bachelor’s degree in engineering field or related field· 2-5 years of experience in high volume regulated manufacturing industry in engineering field.· Working experience of Six Sigma, lean and Quality Management Tools