Quality Assurance Engineer
Core
Maintain and improve the Quality Management System to ensure products and processes meet quality, compliance, and patient safety standards.
Role type
Quality Assurance Engineer (Medical Devices)
Builds
Precision radiation medicine solutions for cancer care
Domain
Healthcare technology / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality management system maintenance, regulatory compliance interpretation, audit planning and execution, non-conformance investigation, root cause analysis, CAPA implementation, ISO 13485 knowledge, MDR knowledge, IEC standards knowledge, QSR knowledge, MDSAP knowledge, Lean methodology, Six Sigma methodology
Preferred skills
Professional quality certifications (CQI, CQE, CQA), certified auditor training
Responsibilities
Support and lead quality and compliance activities, Monitor quality metrics and analyse trends, Act as a Quality representative in key processes, Plan and conduct internal and external audits, Investigate non-conformances and support corrective actions, Review and approve quality documentation, Partner with cross-functional teams for process improvements
Seniority
Mid-level, hands-on IC