Acumed LLC is seeking a Senior Quality Engineer with expertise in Software as a Medical Device (SaMD) and digital surgery. The ideal candidate will provide quality assurance support throughout the product lifecycle, ensuring compliance with global standards and regulations
Job Summary
The role provides quality assurance support for the development, production, and lifecycle management of digital surgery and custom implants.
Candidates must ensure compliance with global standards including FDA regulations and ISO 13485 while guiding cross-functional teams through software validation.
The position involves leading risk-based decision-making, managing non-conforming material reports, and driving continuous improvement in QMS processes.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Senior Quality Engineer with expertise in Software as a Medical Device (SaMD) and digital surgery. The ideal candidate will provide quality assurance support throughout the product lifecycle, ensuring compliance with global standards and regulations.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Software as a Medical Device (SaMD)
ISO 13485 compliance
FDA Quality System Regulation
CAPA investigations
Root cause analysis tools
Design control processes
Nice-to-have
6 Sigma proficiency
Minitab statistical analysis
GD&T understanding
SAP ERP system knowledge
Cross-functional leadership
ASQ Certified Quality Engineer
Key Requirements
Bachelor's degree in engineering or science
Minimum 5 years in regulated quality assurance
Experience with implantable medical devices preferred