Senior Quality Engineer - Fixed Term Contract
Core
Ensures Quality System functions comply with documented procedures and regulations for the Infectious Diseases Business Unit.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Compliance with global medical device regulations and internal quality standards
Domain
Healthcare / Medical Devices / Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (ISO9001/ISO13485/cGMP), CAPA investigations, root cause analysis, audit support, problem-solving, regulatory knowledge (FDA/CE/IVDR/MDSAP), data analysis, procedure development
Preferred skills
Audit experience, international travel
Technologies
MS Office (Word, Excel, PowerPoint)
Responsibilities
Investigate complex product quality and compliance issues, identify deficiencies in quality systems, develop effective quality metrics, update and create quality procedures, participate in internal and external audits, implement CAPA system, train lower level employees
Seniority
Senior, hands-on IC
