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Director of SaMD Quality & Regulatory
Job in
Cleveland, Cuyahoga County, Ohio, 44101, USA
Listed on 2026-08-31
Listing for:
Kinomatic
Full Time
position Listed on 2026-08-31
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Kinomatic is seeking a Quality Assurance Director to build and own the QMS for our orthopedic surgical planning SaMD. This leadership role will drive quality across software development, product delivery, and regulatory compliance.
You will lead ISO 13485, IEC 62304, and ISO 14971 activities, establish design controls, risk management, and CAPA, partnering with engineering, product, security, and leadership to embed quality throughout the product lifecycle.
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