Top 5 Skills Necessary to be an Effective Quality Engineer

Here are the top five skills I use at work every day:

  1. Attention to Detail – Catch small issues instead of waiting for a bigger problem.
  2. Willingness to Question–everyone and everything. The QE is the voice of the customer. Company titles and positions should not block a line of thought or an investigation. See ISO 13845 5.5.1 Responsibility and authority: “Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.”
  3. Tendency to Think in Terms of Processes. The ability to look at things that happen as the result of processes vs. the fault of the people involved is essential. Processes can be improved to produce the desired outcomes. See ISO 13485 7.1 Planning of product realization: “The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).”
  4. Ability to Participate in and Lead a Team. The nature of Quality Engineering is to participate with teams.
  5. Technical Skills such as Applied Statistics, Root Cause Analysis, and CAPA. While there are references to these activities in ISO 13485, see W. Edwards Deming for the philosophy behind these activities. Read anything by Douglas C. Montgomery for applied statistics. Check out one of David Auda’s Root Cause Analysis workshops for really good information on that topic. He is currently the ASQ Reliability Division Chair.

Please comment with important skills that I didn’t mention.