Quality Systems & Technical Documentation Specialist – Medical Device Software (SaMD/SiMD)
imfusion
About this role
A Quality Systems & Technical Documentation Specialist in our Quality Management team supports the creation of technical documentation for medical device software (SaMD) and integrated systems, ensuring compliance with regulatory standards such as ISO 13485, MDR, and FDA. The role involves working closely with software development teams to improve documentation processes and contribute to audits.
Skills
About imfusion
imfusion.comImFusion GmbH enables rapid innovation in medical imaging by providing consulting, R&D, and software solutions that help engineers and medtech teams build and deploy advanced imaging applications quickly. Their offerings combine practical software tools and expert algorithm development to accelerate prototyping, image processing, visualization, and integration into product or clinical workflows. ImFusion focuses on shortening the path from concept to deployment so teams can iterate and bring imaging products to market faster.
About imfusion
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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and employee contacts for imfusion.
Salary
$59k – $81k
per year
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