I’ve been too busy lately to give an update on the status of Creo Quality, LLC. This, of course, is a good issue to have. Since mid March 2007, I’ve been working exclusively with two clients.
With one client, I’ve been able to provide a variety of services to support their clients:
- part of a QSIT audit team
- created a GLP remediation project plan
- helped draft a development / commercialization process overview
- coordinate a trace matrix to track warning letter and 483 observations
- provide feedback and input into product design specifications
These “projects” have allowed me to utilize my versatility and experience with product development, regulatory affairs, quality systems, and project management. Some have suggested that I cannot do all these things and that I need to focus on one of these particular skill area. To me, the jury is still out on this. A big part of me believes the variation and my diversity have positioned me well to support this client.
My other client is a start-up medical device company. We are in the process of developing a product, company, and all the infrastructure and stuff that goes along with this. We will be pursuing 510(k) clearance later this summer. My role with the start-up shifted dramatically in mid March (the same time I went 100% on my own). I’ve been working with the start-up since October. My role from then until March was quality manager with my primary responsibilities entailing quality system procedures, work instructions, forms—documentation. I had limited insight and details regarding actual product development activities. And then, my role changed. I guess it was partly timing and partly background and partly me being nosey. One of the device components includes a disposable part. I worked for many years in product development of single-use, disposable medical devices. I started asking some questions about development activities. And then the CEO started asking me about my interest in managing the project. Apparently, there had been some need for some time. Until that moment, the decision makers were not aware of my previous experiences and abilities. Anyway, I’ve been getting an understanding of the project status and spent most of the last month revising and updating the project plan. It’s been fun (seriously).
I also have been in discussions with a third client to support some design control activities. This is yet a different focus and taps into my experience and skills. Maybe the results are in? Each client represents different challenges, are in different stages of maturity, have different types of products, and have engaged me in different types of projects. I’m having a blast.
