3 ISO 13485 Jobs in West Yorkshire

medical equipment work or internal project work. - Produce and update procedures that are relevant to their own area of expertise to maintain the RTS ISO 9001:2015 quality management system. - Teach and train members of staff in own area of expertise. - Carry out and organise internal resource management including … fault finding, preventative maintenance & calibration principles for complex equipment. - Advanced interpretation and creation of technical documentation. Medical Equipment Management: - Advanced understanding of RTS procedures, ISO standards, and Medical Device Regulations. - Participate in on-call system for equipment management services outside of normal working hours. Clinical & Scientific Support: - Provide technical … of knowledge. Professionally registered Clinical Technologist, Clinical Scientist or HCS Practitioner Desirable Formal leadership or management training Specialist medical technical training courses Accredited UKAS ISO 9001 and UKAS ISO 13485 training courses Skills & Behaviours Essential Evidence of fault analysis, diagnosis & repair skills for complex equipment including linear more »

Basic software development skills Electrical analogue and digital measurements Experience with Xilinx MPsoC is a plus Experience with FPGAs is a plus. Knowledge of ISO 13485, MDD/IVDD, IEC 60601x, ISO 14971 is a plus Knowledge of Risk Management processes (DFMEA, PFMEA, AFMEA), DHF, and Tech more »

At least relevant technical experience Experience in nucleic acid assay development Commercial in vitro diagnostic product development experience Knowledge of Quality Management & Regulatory frameworks (ISO 13485, FDA 21 CFR 820, cGMP) Previous line management experience If you're ready to make a substantial impact in the realm of more »