Design Quality Engineer 80 - 100 % (w/m/d)
Core
Design Quality Engineer supporting the development of intelligent mechanical ventilation solutions for adult, pediatric, and neonatal patients in critical care settings.
Role type
Design Quality Engineer (Medical Devices)
Builds
Mechanical ventilation devices and related consumables
Domain
Medical Devices / Mechanical Ventilation
Required skills
Quality Assurance, Document Control, Risk Management, Regulatory Affairs, Root Cause Analysis, Corrective Action Planning, Supplier Quality Management, Statistical Process Control (SPC), Audit Support, Training Delivery
Preferred skills
Experience with international medical device regulations, Hardware/Software/Consumables domain knowledge, Regulatory authority communication
Technologies
ISO 13485, ISO 14971, IEC 62304, ISO 62366, ISO 80601-2, 21CFR Part 11, MDR 2017/745
Responsibilities
Integrate QA, Document Control, Risk Management, and Regulatory Affairs into development projects; Coordinate internal handling of non-conforming products and external complaints; Collaborate with suppliers on quality deviations; Support regulatory requirement interpretation and risk assessments; Assist in internal and external audits; Capture and analyze quality metrics using SPC; Plan and conduct quality training.
Seniority
Mid-Senior, hands-on IC
