Acumed LLC is seeking a Senior Quality Engineer to provide quality assurance support for digital surgery and custom implantable devices. The ideal candidate will have experience in regulated environments, particularly with Software as a Medical Device (SaMD), and will be responsible for ensuring compliance with global quality standards
Job Summary
The Senior Quality Engineer provides critical quality assurance support for the development and lifecycle management of digital surgery tools and custom implants.
This role ensures strict compliance with global regulations including FDA Quality System Regulation and ISO 13485 while guiding cross-functional teams through design controls.
Candidates will lead root cause determinations, manage non-conforming material reports, and drive continuous improvement activities to maintain patient safety standards.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Senior Quality Engineer to provide quality assurance support for digital surgery and custom implantable devices. The ideal candidate will have experience in regulated environments, particularly with Software as a Medical Device (SaMD), and will be responsible for ensuring compliance with global quality standards.