דרושים בתחום מהנדס איכות

· Responsible over the maintenance of the quality system procedures by verifying their compliance to relevant regulatory requirements
· Responsible over supplier/ subcontractor approval
· Responsible over supplier/ subcontractor evaluation
· Responsible for customer questionnaires
· Responsible for preparations for periodical management reviews
· Participation in external audits (notified body and customers)
· Perform internal audits
· Perform supplier audits
· Maintenance of the risk management file
· Write and update quality system procedures
· Support activities related to quality system training
· Support other QA dept activities- second approval of batch release, CAPA/ Corrections, customer complaints, QA agreements, QA monthly report, KPIs.

· Experience:
o At least 4 years working in quality system at Medical Device/ Pharma. industry
o A qualified auditor
Preferred Knowledge, Skills and Abilities:
· Courses on topics related to quality system in the medical device/pharma industry