Need help and a Specific Regulation relating to 510(k)

**MIREGMGR** · #9 21st August 2012, 01:07 PM

Yep. Time to bail out.

*DjfunkmasterG* · #10 23rd August 2012, 10:55 AM

Yeah, that is what i figured. Luckily I have been hit up by 8 head hunters in the last 22 hours since I posted my resume online yesterday.

This is just a nightmare, and a major migraine.

Thanks for your advice and help everyone.

*** off topic, sort off - I remember my days of being an individual contributor... I didn't have these kind of problems. Maybe it is time to roll back to a senior lead Specialist, as opposed to a Manager or in my case a Director.

It just seems too many companies are taking too many risks with the FDA and CFR/QSR (this company isn't the first i have worked for to pull this stunt, but the 1st in which i was the director of QA.)

	The Deming PDCA Cycle	ISO 9001 QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation