|Job Ref:||204573101||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Northampton||Address:||Post Code:||NN1||Salary:||£40000 - £50000/annum||Post Date:||19/10/2016 09:48|
This varied senior level job is based in the medical devices sector.|
The successful candidate will assume responsibility for all quality matters within the plant, - including regulatory and FDA compliance, - and promote quality achievement and performance improvement across the organisation. Company distributes to the EU and US markets.
ISO and other regulatory compliance. Please note that knowledge of 13485 CE Medical directory is essential.
CE kite-mark - product registrations with global authorities
Setting up controls and documentation
Co coordinating product trials
Quality system development and improvement
Agreeing in house standards
Auditing quality system and validating clean room, sterilisation and software processes
Supervising supplier audits
EHS risk assessments
The position also includes working closely with purchasing staff to establish supplier quality performance criteria and assessing suppliers product specifications and quality plans.
Northamptonshire based with occasional travel