Senior Medical Device QMS Quality Engineer

Gener8 | The RND Group is seeking a Senior Quality Systems Engineer to maintain and improve a FDA‑regulated QMS and ensure compliance with QSR, ISO 13485, IEC 62304, and ISO 14971. You will assess DHFs and client QMS with recommendations and drive quality improvements.

Responsibilities include leading assessment projects, authoring procedures, and training teams on software lifecycle processes, with occasional travel to client sites.