Quality Systems Specialist – Up to 45k – Wokingham
A Quality Systems Specialist is required by a medical device manufacturer to work on projects ensuring quality compliance and ensure teams are supported. This role is based in Wokingham and will be home based initially and reviewed ongoing.
As a Quality Systems Specialist, you will:
- Work on establishing and maintaining the Quality Management System (QMS)
- Support quality projects such as the implementation of new or revised standards such as FDA CFR820 and MDR (Medical Device Regulation)
- Provide compliance support related to FDA CFR820, MDSAP, ISO13485, ISO9001 as well as CE Certification
- Use the QMS to support documentation, translations, SharePoint and C2C notifications
Experience required for a Quality Systems Specialist includes:
- A degree and 5+ years quality engineering/compliance experience within the medical technology industry
- Previously worked in an FDA regulated environment
- Knowledge of US FDA 21 CFR 820, ISO 13485 and 9001 and Medical Device Directive 93/42/EEC requirements
- Familiarity with MDSAP regulations
The ideal candidate will have knowledge of risk management and be confident using MS office applications to present data. The role is remote with occassional travel to the office in Wokingham.
To find out more, please email [email protected] or call 01865 546046.
Keywords: quality| specialist| medical| FDA| ISO13485| data| SAP| QMS| SharePoint| QMS| MDSAP| medicaldevice
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency