Quality Assurance Engineer

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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.