My role and prior MedTech QMS experience
Clarissa Archer, a Quality Assurance Engineer at Harmonic Bionics, shares her decade-long journey in the medical device industry. Beginning in product development, she transitioned to quality assurance, drawn by her passion for risk analysis and compliance. With a biomedical engineering background from Texas A&M, she emphasizes the importance of hands-on experience in understanding regulations in the medical device space.
Transcript

[00:00 - 00:10]
So my name is Clarissa Archer. I am a quality assurance engineer at Harmonic Bionics, and I've been here for just under a year.



[00:10 - 00:17]
But prior to that, I've worked at other medical device companies, and so I've been working in the medical device for about ten years now.



[00:17 - 00:34]
So I started out in product development, so I was designing knee hip and shoulder implants and then eased into quality because I really enjoyed kind of the risk analysis role helping make sure that what we were doing is per the regulations.



[00:34 - 00:39]
Yeah. So I actually have a degree in biomedical engineering from Texas A&M.



[00:39 - 00:48]
That program is primarily based on design or the mechanical aspect of product development.



[00:49 - 00:57]
Primarily, my quality qualifications came from learning and working in the medical device space.



[00:57 - 01:09]
No matter what you're doing in the medical device space, you're always going to be working with compliance and regulations and making sure that you're following the rules of the FDA, of the EU, those sorts of things.

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Transcript

But what we've known from what I experience was, is we were able to get there with the system. We still there with the system. The system has what is needed to provide us what we're looking for, because every company, admittedly, is trying to get compliant. If we educate people, if we get people the education that they need and to get over the fear factor, I think 90% of those things can be resolved because most people will go to what they're most familiar with.What I worked with from a different company, but they're not willing to sit down and look at what the demographics are saying. People are into social media now. People are moving fast into fast paced world. But technologies are still antiquated. So there's a disconnect here, right? So while we're moving at a fast pace at home with dragging at work, so why can't we continue that speed while we at work?If your supplier has issues and you're not informed on time, you want to have an alternate supplier in place. If your suppliers are not qualified, you may not know that that needs to happen. And so when you have an integrated system that speaks to itself and is giving you all this data, you literally have the pulse of the organization in your hands as an executive at a money bound access.

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