Vincnet-
(Disclaimer- like Cari and Claes, we're not in the medical device industry)
The correct answer should be, "everyone in any organization is part of the quality program"
Whew!! I gotta slow down on these energy drinks!! OK, back to reality.
My department consists of me, two full time inspectors, one part time assistant for them, and backup from the crew in Performance Testing if needed. We audit supplier quality and perform in-process and final inspection for our manufacturing processes. 300+ employees total, basically 3.5 QA employees and backup as needed, call it 2%.
That is for dimensional, 'fit, form and function' type stuff. There is a separate sort of sub-department, Performance Testing, that does the 'how much water is this pump gonna shoot out and how high?' type stuff. They are in kind of a grey area between Quality and R&D. If we put them in the mix it would be 6.5 employees in Quality total among, at last count, 312 overall.
If I'm not making sense please forgive me. I was recently in a fairly violent auto accident (flipped my truck four times on I-95 and there was nothing left of the truck but a debris field), I'm at work at 7:30am on a Saturday, and the ibuprofen hasn't kicked in yet.
Regards -John