2 of 2 ISO 13485 Jobs in Northern Ireland

26N/SFTM - Software Test Manager

Location
Randalstown, Northern Ireland, United Kingdom
Ranorex, Playwright, Selenium, Test Complete Ability to develop source code/scripts with at least one programming language. Knowledge of IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality systems and IEC 62366-1 usability engineering or comparable standards for other regulated sectors. #J ...

Senior Manufacturing System Engineer

Location
Belfast City District, Northern Ireland, United Kingdom
access management and continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans ...