Grace Hoffman

Background

About Grace Hoffman

Hello! I am currently a member of the Quality Engineering Development Program (QEDP) at Medline. The program is two years long, and I am a little more than halfway through it. I spent 12 weeks learning how to be a quality engineer at Medline through high-intensity training, learning 21 CFR 820, ISO 13485, and how to evaluate packaging and validations. I am gaining as much experience as possible in areas critical to compliance and job functions. After the 12 weeks, I spent 9 months on the corporate quality side of my rotation, where I had the privilege of working with the amazing surgical and exam glove teams. About three months into this rotation, I was given the opportunity to become a lead and point person on projects and within the surgical glove team. Through this opportunity, I have been able to learn about the different regulations for surgical gloves worldwide. One of my best experiences during this time is being able to finish the documentation for the synthetic surgical glove portfolio to bring the product from MDD to MDR regulation in the EU. This was a huge challenge and gave me the ability to work with the broader regulatory teams and gain experience with international regulatory bodies like SGS, MDSAP, and BSI. In July of 2024, I ended my time in corporate quality and changed fields to drug, cosmetic, and over-the-counter drug manufacturing. Which is a massive change from the medical device regulations that I had spent the last 9 months learning. Over the next year, I have been given the privilege to learn from teams that have been making Medline products for years and have seen the process and the drug regulatory space change over the years. I hope to gain the knowledge and wisdom from their many years of experience by working alongside them. Over the next year, I will continue to explore the drug manufacturing environment and gain as much knowledge as I can to help me be successful in any role in the future. I am thrilled to announce that I will graduate from this program in June of 2025. I am very excited to see what the future holds thanks to this program.