Description
A medical device client of mine have an urgent need for a Quality/CSV engineer on a contract basis. The role is based in Cambridgeshire and will be a 6 months contract.They are looking for someone to start immediately so the shorter the notice period you have the better. They will be interviewing this/next week so that they can get this finalised as soon as possible. The role will be based in the UK but will be some travel to Paris so would need someone who is able to do this.
The main responsibilities of the role will be:
·Quality / CSV Engineer needed to support the business in developing its procedures in relation to IEC / EN 62366 (Usability with a leading towards automated systems), IEC / EN 62304 (Software Development Lifecycle) and ISO 14971 (Risk Management).
o The review and develop the SOPs used by the business to ensure compliance with these requirements
o Upgrade the company's Technical documentation as far as possible to meet the new SOPs
o Train the QA team within the business to understand the requirements of the new SOPs to ensure that the business can maintain compliance moving forward
o Able to operate on own initiative
o Equivalent prior experience a distinct advantage
o Strong written / verbal English
o Reasonable level of understanding French (verbal and written) would be a distinct advantage, although not essential
If you know of anyone who may be interested we offer vouchers up to £200 for a referral that results in a placement.
Thanks and regards,
Nathan Puxty