I've had to sign a non-compete agreement 3 times so far. First was when I worked for a consulting firm - I was not allowed to work directly for their clients or recommend their employees for hire to m...

Fortunately, I have not yet been laid off and gone through this. However, I have gotten a release letter from when I wanted to leave my consulting firm. They tried to take advantage of the fact that i...

Consultants are generally hired when a company does not have the specific resources for a task/project or the company does not have enough resources to complete task/project on time. In my previous jo...

This week we learned some of the advantages and disadvantages of 3 organization types: Functional, Project-Based, and Matrix. Are there any industries (or even specific companies) you can think of tha...

Every company I've worked for has so far been a matrix organization. While I have not had experience functional or project-based organizations, I feel confident in saying that I would prefer matrix or...

Posted by: @sts27 In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively...

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the...

ISO 14971 is the ISO regulation governing Risk Management and its major requirements for medical devices are: Identify risks Estimate the potential occurrence of risk and evaluate extent of consequen...

I've participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so I was questioned on some things but was able to ad...

I've done and am actually in the middle of a shelf life validation for raw materials and final device. We've included in it packaging, transportation, and storage studies in accelerated and real-time ...

They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood typing machines, aren't chemical compounds made t...

From what I have observed during my working experience in Medical Device companies as Production Engineer, Quality seems to operate under two main strands: Quality (Ops) and Quality (Compliance). As P...

As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have you ...

@bjv9 Yeah, absolutely, some countries have have regulations that are more strict than the US and for that reason some drugs or devices banned in other countries are actually deemed safe in the US. Fo...

My previous employer sells blood typing kits to many countries around the world and we are regulated by several bodies around the world. While most of their focus overlaps other things like labeling r...