Internship Location: Fridley, MN
Organization Type: Biotechnology/medical devices
Policy Areas: Medical device regulation
During Summer 2022, I worked as a Quality Engineering Summer intern at the Rice Creek Medtronic location in Fridley, MN. One of my projects was to design a checklist to ensure recently produced lots of product have all required documentation. This was to address Title 21 Code of Federal Regulations 210/211, which regulates the production of devices containing drug, device, and/or biologic components. The project required investigating 5 unique document repository systems, communicating with a 10 person team, and combing through countless documents to ensure all requirements were met. I also initiated an A3 to address nonconformance report tardiness and inconsistent escalation criteria as a way to practice skills gained from DMAIC training, a popular engineering problem-solving framework. Conducting this analysis was important because the longer a nonconformance report takes, the further delayed the affected product lots are in reaching the market, putting patient lives at risk. Lastly, I participated in an external audit as a scribe, which involved documenting interactions between the auditor, logger, and subject matter experts in the front room to provide greater context for those in the backroom. Being involved in the audit process granted me knowledge on how audits typically proceed, and the extensive degree of collaboration required between Medtronic operating units to maintain quality and uphold proper documentation practices. Overall, I learned a lot about medical device documentation practices and the standards that go into ensuring their quality, which have health policy implications for patients, medical providers, and insurance companies.