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Our client is an established medical technology manufacturer producing molecular diagnostics and point of care devices for the international market.
Due to rapid expansion they have a position for a 12 month fixed-term contract with the Quality Engineering department. There is potential that this may turn into a long term position.
The role offers Hybrid working for those not close to site.
Position
Reporting to the Quality Lead, the successful candidate shall be accountable for maintaining compliance of the Quality Management System, input into the management of complaints and post-market activities ensuring that the requirements of ISO 13485:2016, CFR 21 Part 820 IVDD/IVDR are adhered to.
The successful candidate shall be responsible for carrying out day-to-day Quality Management Systems and post market activities associated with the on-market product. Activities such as document creation and review, input into and performing investigations, vigilance reporting and maintenance of trend analysis are requirements of this role. Effective cross-functional within the business is key to the role.
Responsibilities
- Performing routine QMS activities associated with post market vigilance and complaints to meet the wider business goals
- Prepare and create documents and records for upload on to the document management system
- Review and approve returned product evaluations
- Performing data and trend analysis, providing input to investigations and generation of KPIs
- Continual development of QMS processes and procedures driving lean practices throughout the team
- Providing QA input to investigations supporting timely completion and resolution
Skills
- Maintaining compliance of the QMS
- Ensuring timely completion of post market and vigilance related activities
- Support and input to internal / external audits
Essential
- Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820
- Experience of working on post launch IVD or medical device activities in a quality role
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
