I agree in general with the results of the survey, it makes sense. I think the more interesting question to ask is why do people leave the job they are in? I am in a company right now where a…   Read more»

Having a good relationship with supplier is extremely important. I have worked in Supplier Quality for the last 7 years. I think what @ap962 posted is a great start but one of the most important things is making sure that…   Read more»

I always like to give my suppliers the benefit of the doubt, I wouldn’t assume it’s an ethics issue. An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related non-conformance is found. This…   Read more»

I agree that Americans tend to be overworked. It really does come down to company culture though. I have worked in a bunch of companies and some of them its strictly 8-5 and others the schedule is more flexible but…   Read more»

I would choose to be in the Regulatory group because it is an exciting and ever changing environment. Due to constant changes in the world wide regulations the group that is making sure the trials adhere to current regulations has…   Read more»

I have a Six Sigma Green Belt from my former employer. I also have a Certified Quality Auditor and Certified Quality Engineer. I work as a quality engineer and those are the most requested certifications in my field (At my…   Read more»

I work in a company that has recently experienced high turnover and I can tell you from experience that losing talent and knowledge is a huge problem in the medical device field. As a quality engineer one of the most…   Read more»

I guess my question to you all is how would selecting a different coating from the same supplier reduce sourcing risk? What is the major sourcing risk that is being reduced? Would it be acceptable if (in this case) Conmedics…   Read more»

I disagree with this a bit. It’s true earned value could be skewed, but it should also not be used by itself. It should be presented along with other values to get a complete picture of the health of a…   Read more»

In project management there is a concept known as the triple constraint. The three constraints are cost, time, and scope. The idea being if you want to for example broaden the scope of the project, you would also need to…   Read more»

As a quality engineer, I have always been a huge fan of Metrics. I believe metrics can be a great way to identify problem areas and where you may need to reallocate resources. It is important to note that red…   Read more»

Today has me considering how much weather can negatively affect schedule. This month we have had 5 snow days. Last fall our site in Miami was closed for a week due to a hurricane. Forces of nature are hard to…   Read more»

In this project simulation, Patty wasn’t the project manager but she was a significant stakeholder and team member. The project manager’s job is to mediate between these two personalities. It is possible however to have a difficult project manager who…   Read more»

In a previous Project Management course we were asked to identfy the personality styles of our team members, analyze how those styles might conflict and to come up with a set of ground rules for the project team to address…   Read more»

In my company, the Work Breakdown structure more closely resembles option 2. I have seen various degrees of success with this. I think one of the problems I see occur is that the people providing input into the work breakdown…   Read more»

About 6 years ago the company I work for was developing a next gen drug coated coronarystent. Due to competition, sales were falling from the companies first drug coated stent. The first stent used to be a major money maker…   Read more»

So first of all, regulations are rarely released by surprise. When a government entity releases a new version of a regulation they generally give a company plenty of advance notice and time to comply. What this means for the project…   Read more»

Project planning is very important and critical to the success of a project. Project plans are absolutely living documents that will be updated throughout the course of the project. One way to mitigate the issues you bring up is to…   Read more»

I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following. Industry standards Regulations Previous projects / products Competitor products End-users Prototypes So marketing will certainly have a role in…   Read more»

In my company I support contract manufacturing. So while we also have very similar processes to those mentioned above for internal design changes, I will go into the process when we have a design change at a contract manufacturer. Generally…   Read more»