Quality Inspector

Quality Inspection Technician | Maple Grove, MN Contract-to-hire A growing medical device startup is building out its quality function around a Class III implantable device now in FDA pivotal clinical trial. This is a foundational inspection seat with real ownership: you'll run in-process and final inspection on precision components, subassemblies, and the catheter-based delivery system before they advance or release. Early-stage environment, direct line to a product that ends up in patients. Dimensional, visual, and functional inspection of frames, tissue and textile components, and delivery-system subassemblies using calibrated tools, optical comparators, and microscopy, plus final release, DHR signoffs, and NCR authoring Foundational role where you help stand up the inspection infrastructure, write the work instructions and acceptance criteria, and support root cause and CAPA rather than inherit a finished system 3 to 5 years of quality inspection in a regulated device environment under 21 CFR Part 820 and ISO 13485, ideally with Class III, implantable, or sterile product and fine-tolerance sewn or tissue components, plus GD&T, NCR/CAPA, and cleanroom fundamentals If this is you, or you know someone who fits, send me a message. #J-18808-Ljbffr