Quality Systems Engineer
Belfast, United Kingdom
HIRANI
We are expanding our team and are recruiting a Quality Systems Engineer. In this role you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for the maintenance of the quality system to ISO 13485 standards and associated product certification. As a Quality Systems Engineer, you will: Support … the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System with activities including document control, training management and change management. Draft and update procedures, work instructions, and quality documentation. Collaborate closely with Engineering (Software and Hardware) and Customer Support teams to investigate and identify root causes of quality-related issues from customer … complaints, internal non-conformances and audit findings. Assist with the implementation of CAPAs and closure of non-conformances. Collaborate with cross-functional teams on documentation creation, risk management, and validation activities. Support quality compliance for SaMD products, including lifecycle and version control. Participate in internal and external audits. Analyse quality data and contribute to process improvement initiatives. More ❯
Employment Type: Permanent
Salary: GBP Annual
Posted: