Description
An exciting opportunity has arisen for a Quality Engineer to work in a growing Medical Device organisation.Main responsibilities will include maintenance of the Quality Management System as it goes live from trials, advising senior members of staff and implementing changes that will need to be made when the system goes live.
The ideal candidate with have experience with class III medical devices and a solid understanding of ISO 13485 in order to correctly maintain the systems correctly.
The certified QMS is being run to ISO 13485 legislated to EU MDDs 93/42, Annex 2007 EEC and to cGMP requirements for MHRA, USFDA and EMEA.
- Relevant Science/Engineering Degree
- Six Sigma qualified - minimally Green Belt level
- Proven experience in Quality Management Systems in a similar role within a medical device environment would be beneficial
- Non Conformance Report Remediation Experience
- Good Data Analysis skills
- Complaint and Risk remediation experience
- Extensive experience of project support to design and validation teams
- Experience of FDA regulations
- Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
If interested please contact SandeepSandhu on