2 of 2 Permanent ISO 13485 Jobs in Wales

work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential. Key Responsibilities: Working within a controlled ISO 13485 and ISO 9001 laboratory quality system and in accordance with GxP procedures. Design, plan and execute Physical Testing in support … environment, within Medical Devices/Pharmaceutical Industry is preferred. Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation. A detailed understanding of common statistical analysis and experience with MiniTab desirable. ...

challenge issues constructively and drive corrective action Desirable Experience within medical devices, automotive, aerospace or another regulated/high-tech manufacturing environment Knowledge of ISO 13485 and/or FDA requirements Six Sigma qualification Experience with injection moulding, pressing or other complementary manufacturing processes Qualifications Degree ...