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    Employee Spotlight

    Meet Gabriele Howard

    Gabriele-Howard-Round-HeadshotGabriele Howard

    System Certification Manager

    Define your role within Nemko.
    I am the System Certification Manager for North America and was hired to help build the System Certification business. We provide Quality System Certifications and help organizations meet various international regulations and standards that allow them Market Access in various countries. Nemko's vision is to create a safer world by ensuring that products and services don’t harm anybody. I have worked with notified bodies, registrars, and various regulatory bodies for 30 years. It's all about the safety and effectiveness of products, and I have worked a lot with medical devices. I was hired 17 years ago by Nemko to offer new services focused on Quality Systems. This is still my role, and we are constantly expanding our services.

    Could you expand a bit more on Nemko’s Quality System services?                                                                                          Often companies will need their products tested, and they also will need to have their quality systems audited and certified. For example, a medical device company will need its ISO 13485 system certification. During an audit, I will also check that the necessary test reports are available regarding product safety, and this is where our lab services come in. So, product safety is a piece of the whole system, but Nemko provides multiple services, which are critical to obtaining market access. I've been asked to provide a new service, ISO 27001, which deals with Information Security Management. This standard helps against Cyberattacks and protects the assets of an organization. Assets could include confidential data, customer lists, proprietary information, design documents, etc. This list goes on. In addition, we have laboratories now that offer Cybersecurity testing, which is another set of services high in demand. The market is asking for more protection against the increasing threats from Cyber Criminals.

    How did you choose this career path?
    I ended up in it accidentally because I used to have my own translation company. I grew up in Germany and knew various languages and was translating IFUs for a laboratory. I had graduated from San Diego State University with a Business Degree and thought of myself as an entrepreneur. While working at the test lab, I was offered a career in sales and marketing, which later led to auditing. Visiting all these different companies and learning about their technologies was fun. Thirteen years later, Nemko hired me to build a new business unit. Companies that were testing with us were asking, "So why are you not offering the ISO 9000? Why are you not offering the ISO 13485?" They hired me to build the system and offer this new service. In this kind of industry, it is advantageous to hire people with a background in these things since the learning curve is long, and I have that experience and knowledge. This opportunity allowed me the role of an Intrapreneur, which suited my personality.

    What do you enjoy most about your job at Nemko?
    I'm an easily bored person, and in this industry, I'm always learning about new technologies and products and am involved with startups. There's never a dull moment in our company, and there's a lot of excitement, which suits my personality. There's always something, a new development, standards change, something new to learn. I also enjoy teaching, training, and explaining since there's always much to be taught. Our customers have many questions, and I enjoy communicating and sharing content to help our customers understand that maze of regulations since new laws and standards are always coming out. There's a lot of confusion, and I enjoy providing some clarity and helping them find their path through all those regulations.

    Are there any challenges that you’ve faced during your career that have taught you important lessons?
    Our customers experience a lot of pressure from various stakeholders. Helping customers overcome obstacles regarding market access can be challenging. Our customers might want market access right now, and often it doesn't happen fast enough. It's hard to create a win-win situation for the customers when there is such pressure to meet timelines. So, finding the balance between meeting the regulations and the pressure of the timelines is challenging because we have to be in compliance but want to deliver for our customers. There's this pull between customer satisfaction and meeting the requirements. I handle that through strong communication with the customers by continuously letting them know the project status and helping them be proactive in what they can do to meet those requirements. Last but not least, I remind them of our common goal, which is to create a safer world.

    What do you think the industry will look like in 20 years?
    There will be a need for more cyber security. We are in a much more digital world, so companies and individuals need protection. We offer new services like the ISO 27001, a standard for information systems that helps companies protect their assets. We need to protect ourselves more from cyber-attacks. I see the world becoming more digital with many more things happening online, which also has a downside because there'll be less person-to-person interaction. I see that there will be more automation, eliminating many jobs since many programs and computers will take over specific jobs, and certain processes will be automated going forward. I think the pandemic already showed us that we needed to be able to pivot. We needed to be able to communicate remotely and work remotely. We need to move with the new technologies instead of being resistant. Instead, ask how can I be part of a changing world and how can I adapt?

    What do you find most rewarding about your role?
    I'm a people person, so I love interacting with our customers and learning about their strategies and visions. I like to support companies' ideas; of course, from the regulatory perspective, I ask how I can help you get to your vision? How can I help you get to your strategy? How can I help you provide market access and coach you through the maze of what you need to do to meet those regulations? That's very rewarding to support their vision and support their strategy. I explain how you can get there and be a part of their team.

    What are some market trends you’re keeping an eye on?
    The market trend I'm keeping an eye on is the increase in cybercrime. Attacks are getting increasingly advanced, and I could easily become a victim if I didn't know what I know. So that is where I see new opportunities because I feel bad for my parents or grandparents, the older generation that might not be as technology savvy. I know companies that were victims of cybercrime, where somebody hijacked all their information and had to pay a ransom. We need to protect ourselves more because so much of our data is now available online, so much data protection is required.

    When not working, how do you spend your spare time?
    Traveling, I'm a global warrior. I'm originally from Germany, and I love different cultures. So, I'm perfect for this job because I've had clients from all over the world and I love languages. I constantly have my Netflix set to different languages with different subtitles. I might watch a Norwegian movie in German with Spanish subtitles. But I like to travel; I've traveled to Europe, I have family in Europe, I also love Mexico, and I love visiting Italy since I'm a big fan of Italian food. So, most likely, I'll be planning some kind of a trip. I always love to communicate with people from different countries, so this is how I ended up in this international company because I am a global warrior at heart.

                                                   Gabbi2          Gabbi4

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