Quality Engineer - Fuze Services - Fixed Term Contract
Core
Ensure medical device products and processes comply with regulations (ISO 13485, 21 CFR Part 820, MDR, IVDR) and lead risk management activities.
Role type
Quality Engineer (Medical Devices)
Builds
compliant medical device manufacturing processes and validated equipment
Domain
Medical device manufacturing / Digital health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk management, change control, validation, audit support, CAPA investigation, root cause analysis, regulatory compliance, technical writing, ERP systems (SAP QM)
Preferred skills
Six Sigma, Minitab, auditing certification, statistics, Lean
Technologies
SAP S/4 HANA, Minitab
Responsibilities
Evaluate products and processes for regulatory compliance; Review and support change controls and design changes; Review and approve validation deliverables; Participate in internal and external audits; Lead risk management activities; Handle customer complaints and corrective actions; Analyze non-conforming product disposition; Support CAPA investigations and documentation; Stay updated on regulatory changes.
Seniority
Mid-level, hands-on IC
