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QA Manager - medical devices job in Northampton

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Job Ref:  204573101
Employer:  cv-library.co.uk
Industry:  Civil and Structural
Job Type:  Permanent
Country:  United Kingdom
City:  Northampton
Post Code:  NN1
Salary:  £40000 - £50000/annum
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.

Duties include

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
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