Supervisor Design Assurance (m/f/d)
Core
Lead the local Design Assurance team in Berlin while actively contributing as a Design Assurance Engineer to ensure product quality and regulatory compliance for medical devices.
Role type
Supervisor Design Assurance Engineer (first-line supervisor)
Builds
Medical devices and consumables for mission-critical applications (minimally invasive surgery, robotics, 3D metal printing)
Domain
Medical devices / Healthcare / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, risk management (ISO 14971), FMEA, quality planning, V&V strategies, statistical methods, system/hardware/software testing, calibration management, failure analysis, NC/CAPA
Preferred skills
Team leadership, experience in automotive or aviation regulated industries
Technologies
ISO 13485, ISO 14971, FDA 21 CFR 820, GLP, GDP
Responsibilities
Provide first-level leadership to the local Design Assurance team; Create overall quality plans and review design verification and validation plans; Act as a member of the risk management team ensuring completeness of risk analyses; Contribute to Product/Design FMEA activities and manage calibration of measuring equipment; Ensure strict adherence to quality, occupational safety, and environmental regulations.
Seniority
Supervisor, first-line leadership
