Amanda Streit
Administrative Assistant/Project Manager
Define your role within Nemko.
My role has evolved since I first started at Nemko. I began as an administrative assistant for Lori, helping prepare and get audits on the schedule. Since that time, I've taken on auditing training for the ISO standards for ISO 13485 and the new ISO 27001, which is cybersecurity. Within the last year, I've moved from the administrative assistant role to fully taking over factory inspections from our unit, NRTL. I have been responsible for handling all of the United States inspections. It's been a giant learning curve, but I have had support to take on this new responsibility.
How did you choose this career path?
I chose this career path because of my previous experience with biotech companies and the medical device standard ISO 13485. I have a Bachelor of Science degree in Biotechnology; Gabby saw something in me to want me to progress and take the initiative for auditing training. I have received a Lead Auditor Certificate in ISO 13485 and finalizing my second course in ISO 27001. The progression that I have made at Nemko has been quite a bit over the last 4 plus years. I have experienced hands-on audits in ISO 13485, ISO 9001, MDSAP and assisted with a MDD audit. During ISO Audits, I find it interesting how companies take an idea, and with Nemko’s audits, it can be released and available on the Market. More recently, my position has evolved into taking over factory inspections. The role has provided a huge learning experience, and I am trying to organize the inspections that run more smoothly.
What do you enjoy most about your job at Nemko?
I enjoy working with coworkers to help each other and enjoy when coworkers are willing to share some of their feedback about a project. My strengths in this position are my ability to be organized and to keep track of my projects. I enjoy going to tradeshows for the purpose of learning about other companies and how Nemko could assist their company. Working with my ISO sisters and other co-workers has provided a reason why I enjoy my job, and the guidance and training from them has been greatly appreciated.
Are there any challenges that you’ve faced during your career that have taught you important lessons?
The main challenge that I have faced recently was over the USA NRTL Inspections. My duties changed quickly, and we had to adjust and make several changes to our process so that I would not delay our inspectors. The most important lesson I learned was patience, double-checking your work, and acknowledging that it can be just one moment when things overwhelm you, but you must keep moving forward. I've had several moments when I'm on a phone call with my coworker Garnet, and we talk about just focusing on one thing at a time. You can't look at the big picture it will only overwhelm you... Just take one piece at a time, and then it comes together.
What do you think the industry will look like in 20 years?
Nemko as a company will be around but will still be constantly changing as technology is only changing more rapidly. For my position in the company, I see two different points of change. For factory inspections, they are growing so quickly this year. I believe our factory inspections will grow to the point where it will become its own department because Nemko requires it for testing. For ISO, our department is changing in another way where we aren't doing the MDR. We are trying to find a new market niche within cybersecurity (ISO 27001) and grow the ISO 13485 and ISO 9001 standards. We have hired two new outside salespeople who can promote innovative ideas and bring in new clients to Nemko.
What are some market trends you’re keeping an eye on?
I have always looked at the FDA and have followed the news regarding the medical economic market. In the last year, the FDA proposed the idea of harmonizing the QSR with the ISO 13485 standard. What this means for Nemko is potentially opening the market to clients who need ISO 13485 Certification. For the medical economic market, I see a growing trend that the cost related to the MDR will force the smaller medical device companies out of the European Market. We have already seen clients that could not afford the close to $0.5 -1 Million costs for the MDR. They may choose to sell only within the USA or be forced to sell to larger Pharma companies. This will eliminate competition and drive up medical costs as they have pricing control.
When not working, how do you spend your spare time?
I love photography and crafts I've been doing those for years, so I keep myself busy with thinking of projects that I want to create My other hobby that I enjoy all year long is gardening, I have a greenhouse, so I have been able to try and grow Fruits and veggies. Lately, I've been traveling to Texas and Arkansas to visit family. Traveling to new places for me is on my bucket list. Next month I will be going to see the natural beauty in Utah with hopes of taking pictures at the Arches, Zion National Park, and the North Rim of the Grand Canyon. Last year’s trip was to the Sequoias, and that was beautiful.
What does the average day in the life look like for you?
Just keeping busy, and trying to remember what I was just working on. Factory inspections are my primary duty, along with doing ISO prep for our auditors. ISO 27001 and ISO 13485 Lead auditor training are also on my goals list. This week, I am preparing to take part 2 of the ISO 27001 Lead Auditor course test. I have trying to stay focused on my test prep. The average day starts with a general list of "need to get completed objectives". Some days that may not happen each day is different the incoming emails change the direction of my day. As the Project Manager for factory inspection, I cover all inspections for the US and Mexico inspections. We get new factory requests daily, so I have to adjust and make sure they are addressed and scheduled.
What is your favorite song, show, or book at the moment?
For television, I just got caught up on Young Sheldon I just started watching recently, but I enjoy it. I also love baking shows, real-life crime shows, and The Amazing Race. For music, I listen to Kelly Clarkson I like Little Big Town and Lady A (I have seen them all in concert). The last book I read was in May it was a mystery book called Where Are the Children Now by one of my favorite mystery authors, Mary Higgins Clark. This was her final book and was released shortly after her death. I've read every one of her 30+ books out on the market, and I have been reading them since high school. I definitely recommend them!
