Quality Systems Manager
Skipton, Gargrave, North Yorkshire
Our client has a new and exciting opportunity for an experienced Quality Systems professional to be responsible for the Quality Management System to ensure they are regulatory compliant (EN ISO 13485:2016, FDA Code of Federal Regulations, 21 CFR Part 820 QSR, Medical Device Directives 93/42/EEC/2007/47/EC). You will also be expected to coordinate the CAPA activities, as well as the Internal Audit and Training programmes. You will ensure the compliance of facilities Risk Management Files in accordance to ISO 14971 and support regulatory submissions requirement to RA in both Gargrave and San Antonio sites. Organised and meticulous, you will maintain the Documentation Control System and take an active role in identifying QMS requirements and driving changes in procedures and standards. An influential individual, you will demonstrate best practices in line with the site strategic objectives.
Educated to degree level or equivalent in Quality, Engineering or Science, you will have substantial experience in a medical device / pharmaceutical regulated environment combined with knowledge of FDA, ISO 13485 and other regulatory country specific standards. You will be self-motivated, have a proactive approach to work and have the ability to prioritise and plan workloads, whilst meeting tight deadlines. Flexibility around core hours is a must to ensure that high standards are met as is the ability to forge strong working partnerships with key stakeholders and internal client groups.