Content Library

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.

Join the discussion

0 comments

Active Here: 0
Be the first to leave a comment.
Loading
Someone is typing
No Name
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your comment will appear once approved by a moderator.
No Name
Set
This is the actual comment. It's can be long or short. And must contain only text information.
Edited
Your reply will appear once approved by a moderator.
Load More
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Load More
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.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Unifize Results

10x
Speed to compliance
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices
4x
Faster time-to-market
Map Unifize to your processes and streamline workflows, process automation
70%
Fewer meetings
Less meetings with in-app collaboration, real-time updates, and decision logs
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.

View More Case Studies
Video icon

Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

Video icon

Here’s how Harmonic Bionics slashed time to market by 80%

Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.

Video icon

Will-Burt's game changing boost to quality process cycle times

Learn how The Will-Burt Company was able to implement and adopt a new quality management system across 8 collaborating teams in less than a day and streamline internal / supplier non-conformances, customer complaints (VOCs), internal / supplier audits, 8D reporting, corrective actions and preventive actions.