QA Specialist - Design Control (12 month temporary position)
Core
QA Specialist supporting the IVDR transition for legacy cancer diagnostic reagent devices by managing design documentation and ensuring compliance with regulatory requirements.
Role type
QA Specialist (Design Control)
Builds
Design documentation (DHF, SSP, GSPR) and regulatory submission files for in vitro diagnostic reagents.
Domain
Medical devices / In vitro diagnostics / Cancer diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, Quality Assurance, Regulatory compliance (IVDR, ISO 13485, ISO 14971), Documentation review, Continuous improvement
Preferred skills
Knowledge of IVDR, Danish language
Technologies
None stated
Responsibilities
Review and approve newly created or updated documentation, Develop, maintain, and share best practice examples, Drive continuous improvement in design documentation processes
Seniority
Mid-level, hands-on IC