Description
Software Quality Engineer - BedfordWe are looking for both a Contract and Permanent Software Quality Engineer to join an organisation in Bedford.
This position specifically provides quality assurance expertise and facilitation with the company and assisting the various design and development project teams to deliver projects that comply with all relevant Quality System and Regulatory requirements with a focus on both embedded and support software compliance.
You will be part of the Design Compliance Team in Quality Assurance
In order to achieve the above the role holder will be able to ;
- Demonstrate the requisite level of experience within IVD or Medical Device Industry (or equivalent regulated industry could be considered)
- Demonstrate a thorough knowledge of US FDA 21CFRPt820 (QSR) and ISO 13485:2003 regulations and standards, in the general area of Design and Development Control and specifically how these relate to software development.
- The successful candidate should be able to demonstrate relevant working knowledge of the following state of the art standards;
- IEC62304, FDA Guidance on software validation, GAMP5
- ISO14971 and its' application to software development as part of a system
- IEC/TR, AAMI TIR36:2007, ISO27002, 21CFR Part 11
- Have experience of internal auditing of software developments
- Demonstrate excellent written and oral communications with internal colleagues and external organisations as appropriate
- Demonstrate strong organisational skills, including ability to prioritise own work in line with timelines
If you think you could fulfill this position on either Permanent or Contract please forward an up-to-date CV and or call;
To find out more about Progressive Recruitment please visit www.progressiverecruitment.com