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Career Story: Medical Device Quality Consultant

Medical Device Quality Consultant

Job Title: Medical Device Quality Consultant

Type of Company: My company helps others bring quality products to market faster.

Education: MS in Biological Engineering

Previous Experience: Worked in product testing and quality and regulatory affairs (dealing with agencies such as the Food and Drug Administration - FDA) for several companies in the medical device product space.

Job Tasks: My job varies from project to project. My skills are used in several areas. I used to write software and still do for a medical image capture system. I write code to automate testing so that tasks that are repeated over and over again and time consuming are automated.

I work in software and product testing. This is to make sure that the product meets its requirements. Requirements are a set of features that a product must have. You can't build a product if you do not know what it is supposed to do. This usually comes from customers or the sales team.

My compliance projects have involved implementation of quality systems and procedures for medical device startups. These are required by the regulatory bodies such as the FDA, ISO (International Organization for Standardization) who mandate a minimum set of rules that companies must follow in order to maintain quality.

I have also represented companies during audits where for example, the FDA comes in to inspect the facility to ensure that the personnel are following established procedures and product quality is maintained.

This usually is a traveling job since most people are expected to be on-site since most changes require someone from quality to approve. I have been lucky enough to be able to mostly work from home.

Best and Worst Parts of the Job: The best part is that you get to work on different projects and products. You also get to choose who you would work for (assuming you get something at the price you charge for your work).

The worst part is that as a consultant, before your project is complete, you would need to get another one lined up so you can keep working. You do not get benefits and are responsible for working, billing (your clients), accounting and finance, and everything else.

Job Tips:
1. You definitely need to go to college and get a degree in engineering or science. Most biotechnology companies need chemistry and biology, device companies need engineering. A Bachelor of Science (BS) degree is minimum, Master of Science (MS) degree gets you an advantage, doctorate (Ph.D.) for scientists is minimum.

2. You need to work in this industry for a few years. Make sure you learn about the industry and do a lot of different kinds of jobs so you learn about how each department works. Always move up in your career not down.

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