Career shift from software quality

Jascentros

Registered
I’ve spent the last 20 odd years in software quality or quality control. I’ve spent most of my career working in the medical device or pharma space doing software quality. I am currently working at a company that builds software for pharma companies. I’m familiar with a lot of the medical device and pharma software regs and standards, 21 CFR 820, 21 CFR part 11, ISO13485, ISO14971, IEC 62304, just as examples.

At this point in my career, I am very burned out from doing technical work and managing technical staff. I need to do something slightly different.

I’ve been thinking about a shift into quality management, or something not managing testing. I am just starting the thought process on this. Has anyone made a similar shift and can you offer advice?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome Jascentros! I am sorry for the delay in this response.

It is very common to move from technical into managerial. I am glad to hear you have been managing technical staff. How is that working for you? It is easier to learn QA Management than to turn an unsuited technical expert into a leader. I have some questions:
  1. What is your educational attainment so far?
  2. Have you discussed your interest in expanding with anyone in your organization?
  3. Have you reviewed job descriptions in your organization to see what they call for, and if they seem appealing?
  4. Does your organization have a leadership development program you can sign up for?
  5. Does your organization have education and training support for higher education? There are programs for QA Management as well as the broad-subject Organizational Leadership at the Masters level.
  6. Have you done any internal auditing? That would help you get a look at areas outside of your experience so far.
  7. Have you looked at any certifications? Reviewing the Body of Knowledge for them can give you some insights as to the responsibilities for each.
 

Tidge

Trusted Information Resource
I avoided the exact burnout described in the OP by actively engaging with my direct reports and lower-level technical peers (not all reported to me) on how to develop them in their careers. The more engaged ones became better workers which lightened my technical load.
 

QuinnM

Involved In Discussions
Hi Jascentros,
First, sorry for the late response. I was away on vacation. Some good advice above, I'll add a little bit more, or something you could start. Talk to you Quality department, see what they need, or even better ask if there are any CAPA's to work on or own. Become very familiar with the "system" SOPs that are interesting to you. By "system" SOPs I am mean quality manual, CAPA procedure, document control, risk analysis, supplier control, training procedure, internal audits, etc.

Your experience in the technical field would be very valuable in the quality area.
 
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