מדעים/ביוטק

QA Specialist

213021

תאריך עדכון

19/10/2021

תיאור המשרה

Prepare and update of Work Instructions, Test instructions SOP’s  Review of ECO’s. Document, Review & Ensures that Engineering Change Orders (ECO) are adequately completed. Maintain ECO log. Process ECO’s (Update DMR’s and subcontractor)     

CAPA – Perform Rout Cause Analysis, Documents Correction, corrective action and Effectivity. Maintain CAPA log     

Customer Complaints - Perform Investigation, Response to Customer, and Effectivity of Resolution. Maintain Customer Complaint Log     

MRB – Coordinate MRB meetings, Documents MRB, Maintain MRB log     

Review bench test protocols and Test Reports. Ensures Bench Tests are adequately completed by  relevant personnel     

Risk Management: Plan and Risk Analysis Maintenance. Preparation of Technical Files. Preparation of AMAR submissions     

Supervise and review manufacturing activities (internal) and documented records. Ensures records are adequately completed by relevant personnel     

Supervise and review of purchasing records, in-coming inspection and MRB processes. Ensures records are adequately completed by relevant personnel     

Review of DHR and all manufacturing records. Ensures records are adequately completed by relevant personnel     

Maintain and Update of ASL (Approved Suppliers List), review, update and record new supplier evaluation forms     

Maintain MTE Review applicable standards list and updated  Perform internal audits    

University degree in engineering or another scientific discipline     

Experience At least 4 years’ experience in a QA/RA Medical Device industry or 3 years in a Consulting firm     

Competences and skills   

Fluent English      

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