Blogs by Jeramie

Medical device professional based in Boston, Massachusetts with experience in Supplier Quality, Quality Engineering, Manufacturing Quality, Quality Inspection, Quality Assurance, Post Market Surveillance, Internal and External Audit support, and Regulatory Compliance. Proven ability to support FDA-regulated and ISO 13485, 9001 and 14001 medical device manufacturing environments, manage , SCAR, CAPA and nonconformances, and collaborate cross-functionally to deliver safe, compl

The medical device industry doesn’t fail because teams “don’t know enough.” It fails when teams can’t execute under pressure—on the floor, in supplier quality, in CAPA, in audits, and during complaint investigations—where mistakes create regulatory risk, scrap/rework, and patient safety exposure. This issue is reshaping MedTech as we speak.

Quality Engineering isn’t just a job in the medical device field — it’s a responsibility that impacts real lives. My career has been built on this principle. Through hands-on experience, clean room exposure, and a deep understanding of regulations, I’ve become the type of Quality Engineer who not only identifies issues but fixes them fully and prevents them from coming back.

Content drawing from real-world experience in regulated industries, quality systems, and professional insight.