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.

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.

Related Case Study Videos

01:13
Managing retentions with Unifize
Jesse Kolstad underscores Unifize's role in effectively managing product retentions at Biovation Labs. The platform simplifies tracking, ensures adherence to retention policies, and enhances compliance, making retention management more streamlined and reliable.
03:30
How to take the plunge on an eQMS- build consensus across the company
Denis Machoka shares Harmonic Bionics' collaborative approach to choosing an eQMS. The team collectively identified and categorized desired system attributes, ensuring the chosen system reflected the team's consensus. This method involved engaging with vendors that met their defined criteria.
02:03
How Unifize's configurability helped us fight the resistance to change
Tedd Carr highlights the configurable nature of Unifize as a pivotal element in overcoming resistance to change at The Will-Burt Company. He values the software's adaptability, allowing for a familiar feel akin to their previous systems, thus simplifying the transition. The Unifize platform mirrors their old forms but with a new, conversation-driven approach, resulting in a smoother learning curve and quicker adoption among staff, leading to a more relaxed and progressive work environment.
01:08
Problems with managing quality using Excel and Word
The video outlines the inefficiencies and limitations encountered when managing quality systems through traditional tools like Excel and Word. The speaker describes the struggle with document control, lack of true automation, and the inability to effectively implement reminders or systematize processes for quality management. This approach proved unwieldy, manual-intensive, and required significant personnel oversight, posing challenges for a small company with limited quality assurance resources. The transition to Unifize is depicted as a crucial move to alleviate these burdens and enhance the quality management process.
02:15
Three reasons why Unifize is the easiest QMS- Security, simplicity, compliance
Denis Machoka advocates for Unifize as a QMS, praising its exceptional ease of implementation and intuitive design. Drawing a comparison with other renowned systems, he emphasizes Unifize's simplicity and rapid setup, making it a standout choice in the realm of quality management syst
03:08
How was Efco handling Returned Goods process before versus after Unifize
In this video, Carol Wilson from Efco vividly details the transformation in handling the Returned Goods process before and after adopting Unifize. She describes the cumbersome, error-prone system of managing returns via Excel, involving complex tabs and manual notifications, which often led to delays and communication breakdowns. Carol contrasts this with the streamlined, efficient process enabled by Unifize, where automated notifications and a centralized system ensure quick, accurate handling of returns, significantly improving accountability and operational efficiency. This change not only saved time but also enhanced collaboration across departments.
01:47
The problems Tedd faced with managing multiple quality systems
Mired in an archaic quality system since 1994, The Will-Burt Company grappled with a maze of spreadsheets and disjointed programs until Unifize revolutionized their process. Tedd Carr shares how their transition to Unifize's singular platform dissolved the cumbersome task of correlating data across five different systems, unveiling trends and accelerating efficiency in quality management.
01:13
Optimising employee efficiency by setting priorities using Unifize
Seth Bozman discusses how Unifize has optimized employee efficiency at Efco, particularly among supervisors. He emphasizes the platform's role in prioritizing tasks and ensuring that rework and remake cards are processed in a timely manner, reducing unnecessary delays. Seth's account highlights how Unifize supports better resource allocation and task management, contributing to a more efficient operational flow and reducing idle times.
01:52
How Unifize helped us streamline Change Requests
Mikala shares her experience with streamlining change requests using Unifize. She talks about how the platform has simplified the process, improved tracking, and increased transparency. Mikala emphasizes the importance of efficient change management in maintaining product quality and compliance, and how Unifize has been instrumental in making these processes more manageable and effective.
05:04
Problems with managing quality at nutraceutical companies
Jesse Kolstad paints a vivid picture of the recurring challenges he's faced in the realm of quality management. From overloaded file cabinets to underutilized QMS systems, he's seen a pattern of data not being harnessed effectively. Jesse shares his thoughtful approach to quality enhancement, highlighting the importance of keen observation and understanding before diving into reforms, reflecting his depth of experience and commitment to excellence.
01:03
How to effectively utilize Unifize
In this insightful video, Carol Wilson from Efco discusses the critical success factors for implementing Unifize within an organization. She emphasizes the necessity of company-wide adoption, from top-level management to every department, to fully leverage Unifize's capabilities. Carol shares her firsthand experience with the platform, highlighting how comprehensive engagement ensures seamless collaboration and efficiency. She underscores the importance of management endorsement and following through on processes to realize the full potential of Unifize, reflecting on its impact on audits and data management.
02:25
Implementing a collaborative eQMS in 4 weeks
Clarissa Archer recalls the initial days of Harmonic Bionics' adoption of Unifize. While they had experience with systems that took ages to configure, Unifize stood out with its rapid setup. Working closely with the Unifize team, they tailored the system to their unique requirements, finding it far more adaptable than larger systems like Agile.
02:28
Managing the product lifecycle and ensuring efficient traceability with Unifize
Jesse Kolstad underscores the imperative of traceability in regulated industries. Drawing from his experience at Biovation Labs, he illustrates how Unifize seamlessly interlinks finished products, ingredients, formulae, and even packaging artwork. The platform's collaborative nature fosters real-time discussions, merging processes that were once scattered across emails and calls into a unified and efficient workflow.
02:55
Using Unifize to simplify Approval processes
Clarissa explores the simplification of approval processes through Unifize in this engaging video. She narrates the challenges typically encountered in securing change order approvals and how Unifize's advanced features offer a solution. Clarissa is particularly impressed with the platform's flexibility in approval settings and its ability to integrate various processes and documents, which she credits for enhancing project management efficiency and decision-making clarity.
00:43
How Erica uses Unifize on a daily basis at work
In this video, Erica details her daily use of Unifize in managing various quality assurance processes at her workplace. She explains how the platform aids in overseeing finished good releases, tracking sale keys, and maintaining standard operating procedures. Erica highlights the convenience of storing and accessing artwork on Unifize, emphasizing the platform's efficiency in managing document revisions. She notes that while managing revisions was challenging with other systems, Unifize simplifies this process, making it more manageable and less time-consuming. This video showcases Unifize's effectiveness in streamlining complex quality control tasks, underscoring its value in a professional setting.
01:14
Hear about things in real-time and start conversations early on with Unifize's mobile capabilities
Tedd Carr discusses the significant advantage brought by Unifize's mobile functionality to The Will-Burt Company. With a web and cloud-based system, Unifize's mobile app enables their sales force to initiate quality conversations and address customer concerns instantly while on the move. This real-time communication capability has proven to be a valuable tool, fostering timely discussions and swift issue resolution, and is especially praised by those who often work remotely or travel.
03:51
How Unifize helped reduce $60,000 of material cost on just one product
Jesse Kolstad shares a transformative experience at Biovation Labs, emphasizing the power of perspective. With Unifize, he could holistically evaluate their ingredient performance and volumes, enabling him to whittle down from 16 SKUs to just two. This consolidation not only simplified management but also resulted in substantial cost savings for the company.
01:28
How I reduced Mock Recall time down to 18 minutes with Unifize
Jesse Kolstad dives deep into the world of Mock Recalls, often perceived as a compliance necessity and a cumbersome task. Highlighting the typical time constraints faced during certification audits, he recounts past experiences where meeting the set time frames was challenging. With Unifize, Jesse experienced a game-changing shift, significantly enhancing the efficiency and speed of the Mock Recall process.
01:18
Why should a cosmetic ingredients manufacturer consider using Unifize
Wilson discusses the specific benefits of Unifize for cosmetic ingredient manufacturers, focusing on the platform's role in enhancing collaboration, quality control, and regulatory compliance. The video underscores the importance of adopting advanced tools like Unifize in a competitive and highly regulated industry.
01:04
How the Unifize team helped build our customisations faster
In this engaging video, Erica offers a fresh perspective on Unifize's standout customer support. She praises the promptness of the team, often responding within an hour, sometimes even in 10 minutes, ensuring immediate assistance. Erica shares her initial experiences as a new user of Unifize, emphasizing the value of regular team meetings in her learning process. She is particularly impressed by the platform's ability to tailor features to specific needs, such as creating custom PDFs, and the team's proactive approach to fulfilling complex requests. Erica's account highlights Unifize's dedication to responsive and personalized support, making the user experience both seamless and adaptable.

Experience the benefits of Unifize

4x Faster time-to-market

Map Unifize to your processes and streamline workflows, process automation, and prioritization

70% Fewer meetings

Less meetings with in-app collaboration, real-time updates, and decision logs

10x Speed to compliance

Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices

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.