Design Quality Engineer
Core
Ensure design quality and regulatory compliance for high-tech microsurgical instruments throughout New Product Development and design changes.
Role type
Design Quality Engineer (Medical Devices)
Builds
Medical devices for microsurgery
Domain
Medical device manufacturing / Microsurgery instruments
Required skills
ISO 13485 QMS, Risk Management (ISO 14971), EU MDR 2017/745, Design Control, DMR/DHF documentation, User Information Material, NPD processes, Sterilization testing
Preferred skills
PLM systems, Class IIIa+ device experience
Technologies
MS-Office, PLM systems
Responsibilities
Lead and support New Product Development (NPD) and Design Changes ensuring compliance with QMS and regulations (FDA, ISO); Support Verification & Validation activities; Generate and maintain Risk Management File using ISO 14971 principles; Ensure quality assurance during all stages of product development; Update product documentation for MDR compliance; Create, review or approve DMR and DHF documentation; Contribute to User Information Material; Contribute to continuous improvement of internal procedures; Contribute to product reprocessing methodology and testing (cleaning and sterilization).