Validation Engineer – CK Group- Science, Clinical and Technical – Hartlepool

CK Group- Science, Clinical and Technical

CK Group are recruiting for a Validation Manager on behalf of a growing and award winning Medical Device manufacturer to be based at their site in Hartlepool on a permanent basis.

The role:

Take the lead on validation activities for the processes and software related to product design together with creation and execution of validation protocols
Create a plan for necessary revalidation activities based on risk assessment for all equipment, processes, and software.
Perform all activities according to current version ISO 13485 and FDA 21 CFR Part 820.
Help to create risk analysis for new projects related to product development
Create changes and validation strategy for products and processes

Degree or equivalent in an Engineering, Science or Clinical subjects, experience in the Medical Device (MD) and or In-Vitro Diagnostics (IVD) industries in similar position.
Strong knowledge of ISO 13485 and US FDA 21 CFR Part 820
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55180 in all correspondence

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