Quality Specialist – Data Analysis – Up to 45k – Wokingham
A Quality Specialist is required by a medical device manufacturer to support the business through accurate data collection. This role is based in Wokingham and will be home based initially and reviewed ongoing.
As a Quality Specialist, you will:
- Work on establishing and maintaining the Quality Management System (QMS)
- Analyse quality data from a multi-disciplinary international team including; R&D, Engineering, Marketing, Quality Compliance, Quality, Medical and Regulatory Affairs
- Prepare data reports for Legal Manufacturer Management Reviews
- Understand the requirements for data collection and trending linked to the 5 MDSAP (Medical Device Single Audit Programme) jurisdictions
Experience required for a Quality Specialist includes:
- A mechanical engineering degree or equivalent with 3 years+ quality/compliance experience within the medical industry
- Previous experience in an FDA regulated environment
- Understanding of US FDA 21 CFR 820, ISO 13485 and Medical Device Directive 93/42/EEC requirements
- Competency in using Microsoft applications to present data to management
The ideal candidate will be able to commute to Wokingham on occasions and have experience using SAP and SharePoint in the workplace.
To find out more, please email [email protected] or call 01865 546046.
Keywords: quality| specialist| medical| FDA| ISO13485| data| SAP| QMS| SharePoint
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency