Quality Assurance Engineer
Are you a Quality Assurance Engineer looking for a long term contract in Oxford? My client is an R&D organisation who are looking for a Quality Assurance Engineer to join the team for a 12 month contract. The role will hold responsibility for contributing to the development and roll-out of an ISO 13485 compliant quality management system and duties will include:
* Writing and developing Standard Operating Procedures (SOPs) and Work Instructions (WIs)
* Training staff on new SOPs
* Performing internal audits and gap analyses
* Supporting functional teams in adopting SOPs/WIs
* Performing/supporting software validation activities
Essential experience required:
* At least 3 years' experience working in a QA role in a product development environment.
* A high level of initiative with ability to self-manage.
* Excellent communication skills.
* Experience with ISO 13485:2016
Desirable experience includes:
* Experience working in a small company, ideally in the bio-tech or medical device sector.
* Experience with project management (Prince2)
* Experience with Agile development (Scrum)
* Experience with any relevant standards and associated techniques:
IEC 62304 (Software Development)
ISO 14971(Risk Management) & FMEA techniques
IEC 62366 (Human Factors & Useability)
ISO 60601 (medical electrical equipment safety)
IEC 61010 (electrical equipment safety)
GAMP / ISO 80002 (software validation)
* Regulatory experience:
EU IVDD/IVDR, FDA 21 CFR Part 820, PMA/510(k) submissions, CE marking
* Certified internal / external auditor to ISO13485:2016
If you fulfil the above criteria please contact Sasha Booth at IC Resources for further details.