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| תיאור: |
QA/RA Manager for a Medical Device Company:
1. Auditing CE / optional FDA
2. Issuing and approving all SOPs including management and production.
3. Overseeing verification and validation processes.
4. CAPA and MRB ֲ- reporting to management, follow up, statistical analysis of effectiveness
5. Production ֲ- final approval of all production forms. Final release of finished product.
6. Clean Room ֲ- monitoring and follow up.
7. Training ֲ- management of training of production employees, measurement of training effectiveness.
8. Auditing ֲ- production, clean room, engineering documentation, Sales, Purchasing etc. including reports issued to management.
9. Management Review ֲ- Annual management report that includes:
a. Training effectiveness
b. Audit results
c. Production status
d. CAPA and MRB analysis
e. Post Market Surveillance
f. QA Status
10. Production: management of production employees.
יש לשלוח קו"ח כקובץ WORD בלבד!
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| דרישות: |
QA/RA Manager for a Medical Device Company:
1. Auditing CE / optional FDA
2. Issuing and approving all SOPs including management and production.
3. Overseeing verification and validation processes.
4. CAPA and MRB ֲ- reporting to management, follow up, statistical analysis of effectiveness
5. Production ֲ- final approval of all production forms. Final release of finished product.
6. Clean Room ֲ- monitoring and follow up.
7. Training ֲ- management of training of production employees, measurement of training effectiveness.
8. Auditing ֲ- production, clean room, engineering documentation, Sales, Purchasing etc. including reports issued to management.
9. Management Review ֲ- Annual management report that includes:
a. Training effectiveness
b. Audit results
c. Production status
d. CAPA and MRB analysis
e. Post Market Surveillance
f. QA Status
10. Production: management of production employees.
יש לשלוח קו"ח כקובץ WORD בלבד!
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| היקף המשרה: |
מלאה |
עיר/ישוב: |
תל אביב |
תפקיד: |
מנהל |
שנות ניסיון: |
3 שנים |
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