Senior Device Quality Engineer
Core
Ensures medical device combination products meet safety, regulatory, and quality standards throughout the lifecycle from design to post-market surveillance.
Role type
Senior Device Quality Engineer
Builds
Medical device combination products (filling, assembly, packaging)
Domain
Biopharmaceutical / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Design and Development File (DDF) maintenance, FDA/ISO 13485 compliance, Root cause analysis, CAPA management, Process validation, Supplier quality management, KPI monitoring, Inspection readiness
Preferred skills
Pre-filled syringe/autoinjector assembly oversight, Human factors engineering, FMEA/8D methodology, Statistical analysis, Change control
Technologies
ISO 14971, ISO 13485, QMS, cGMP
Responsibilities
Ensure compliance with FDA, ISO, EU MDR, and GSK requirements; Maintain risk management and design files; Review/approve technical documentation; Support process validations and production compliance; Lead investigations for nonconformances and complaints; Monitor site KPIs and develop mitigation strategies; Lead site inspection readiness; Partner with suppliers to resolve quality issues; Support device lifecycle management and post-market monitoring; Act as SME for device quality processes.
Seniority
Senior, hands-on IC
