Harmonic Bionics

How a configurable QMS helps engineers

Michael Hogan · Mechanical Engineer · Harmonic Bionics

In this story

Harmonic Bionics

Michael Hogan underscores the practical challenges engineers face, praising the adaptability of Unifize's QMS. Unlike restrictive systems, Unifize offered tailored functionality without unnecessary overhead, allowing them to align the platform seamlessly with their unique processes, a flexibility he found indispensable.

SpeakerMichael Hogan, Mechanical Engineer
IndustryMedical Devices
Runtime1:48

Transcript

6 passages · 1:48
  1. 0:00

    I would say that what you get is a system that does what it needs to do and nothing more.

  2. 0:07

    Right? We basically got the system out of the box that we configured to the processes that we needed. There was no extra overhead. It was exactly what we needed and there was nothing else because we made the processes that we're following. Right? You literally cannot get more streamlined than that. Any other system that we'd be using is putting us into this box that our company doesn't fit into and the ability to make your own QMS, I think, is useful.

  3. 0:38

    The biggest thing about any quality system right, is that they tend to grow and proceduralize. I think that,

  4. 0:44

    you want to minimize the number of gates or roadblocks that are between, you know, my goal as the engineer to make some improvement or some design update or resolve some issue that we've identified and acting on that change. Right. How do you have as few roadblocks as possible while still capturing all the information that you need to get regulatory perspective and make sure that you're following a correct process?

  5. 1:08

    I think that fundamentally the thing that Unifize does very well about that is that the processes are so customizable that if I find something I don't like, I can go talk to the quality engineer and say, Hey, we need to change this. This is this is wasting people's time. And usually we can sit down and agree on that.

  6. 1:27

    Or maybe there's something I didn't realize. But you know, any individual process has to stand on its own merits or we can cut it right. There's nothing that locks us into anything with Unifize, which I think is really nice.

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