Description
This role will be principally responsible for compliance with all prevailing medical devices standards and leading the creation and maintenance of all technical files, design dossiers and device master records including certification and all other important documentation for devices.Key responsibilities include;
- Assist in the creation and maintenance of all technical files
- Assist in the maintenance and continuous improvement of the established QMS
- Assist in the planning and implementation of internal and external audits
- Ensure CAPA assigned is properly run and implemented
- Support the Group RA/QMS Manager during 2nd & 3rd Party audits/inspections
- Interpret standard, regulatory and customer requirements for implementation of Quality Documentation/Quality Processes
- Routine management of the QMS CAPA plans; liaison with Departmental Heads over system CAPA closure progress
- Control of Internal QMS audit schedule
- Conducting, planning and reporting of internal quality audits with regards to the current process and regulatory requirements
Essential Requirements;
- Bachelor Degree in Quality Management or Business Administrator or equivalent
- 2+ years' experience required in similar position with experience of within an integrated QMS
- A good understanding of MDD, ISO 13485 and QSR
- Some knowledge of EU regulatory requirements
- Auditor certification is desirable
- Training in Quality related fields is desirable
- Experience of irradiation sterilization will be advantageous
- Good written and oral communication skills in English
My client is looking to pay between £20-25,000, depending on experience. So, if you are looking to further your career and move in to management, or if you are in management and looking for a new challenge please send me your CV and I will get in touch shortly.
To find out more about Real please visit www.realstaffing.com