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Clarissa Archer, Quality Assurance Engineer at Harmonic Bionics, reflects on her decade in the medical device industry. Starting in product development, she transitioned to quality assurance, fueled by a passion for risk analysis and compliance. A biomedical engineering alum, she highlights hands-on experience as key to mastering industry regulations.

[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.

My role and prior MedTech QMS experience

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