KLS Martin: Development and manufacturing of specialized surgical instruments and medical technology.
5+ YOEBachelor’s degree in Engineering, Life Sciences, Computer Science, or related field; 5+ years in software validation/CSA/CSV in medical devices; proven cross-functional project leadership in regulated environments; knowledge of FDA/ISO (13485 preferred) and CSA methodologies.
CSA, FDA regulations, ISO 13485, Quality Management System (QMS), Risk assessment, Test protocols, Traceability matrices, Change control, Documentation management