We are a market leading Medical Device company and due to continued growth, we have an exciting opportunity available for a Quality Systems Specialist to join our team in a fully remote position.
As our new Quality Systems Specialist, you will be responsible for establishing, implementing and maintaining the Quality Management System in compliance with business projects and initiatives and will support quality-related projects for implementation of new and revised standards such as FDA CFR820 and MDR.
- Establishing, implementing and maintaining the Quality Management System
- Supporting quality-related projects implementation of new and revised
- Understanding of the requirements linked to the 5 MDSAP jurisdictions
- Provides compliance support related to FDA CFR820 MDSAP, ISO13485:2016 and ISO9001:2015 as well CE Certification.
- QMS – implementation of SWIs and supporting documentation, translations, SharePoint and C2C notifications.
- Proven experience in a Quality Assurance role within the Medical Device Sector.
- Proven and demonstrable experience of the implementation, maintenance and development of an ISO 13485 QMS.
- Strong knowledge of FDA 21 CFR 820, ISO 13485 and MDD/MDR
- Sound knowledge of MDSAP regulations
- Knowledge of ISO 14971
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or call 01189 239 234 and ask for Kris Holmes.
Permanent, Full Time
Additional Salary Info
- Industry Sector Engineering, Utilities