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RssVP Regulatory Affairs and Quality Assurance

I am currently looking for an ethical company in the medical device or pharmaceutical industry that can utilize my experiences including but not limited to the scope of quality, of which I have been responsible for recruiting and adjusting personnel levels, QA Incoming Inspection (components and raw materials using sampling plans from ASQ Z1.4, MIL 105E and in-house specifications for inspections), QA Finished Product Release, Document Control, Complaint Processing, Training Department, Human Resource Department, Safety Department, company annual cGMP Training, Validation, Management Review, Annual Product Review, negotiating tariff rates for distribution, negotiate and approve purchase orders for procurement and most importantly direct contact with any and all regulatory agencies that enter the plant or distribution centers such as: Food and Drug Administration, Department of Health, Office of Inspector General, Environmental Protection Agency, Department of Environmental Protection, and Occupational Safety and Health Administration.

Quality Assurance Director

About Me

Industry:

Healthcare & Medical

Occupation:

Quality Assurance Director

Highlights:

Set up a Quality System for a Convenince Kit Manufacturing company meeting the 21 QSR 820 requirements.
 

Education level:

Associate

Will Relocate:

Yes