Quality Engineer

Gap Personnel Holdings Ltd
£50000 - £60000 per annum
07 Oct 2016
20 Oct 2016
Contract Type
Quality Engineer £50,000 - £60,000 Runcorn gap technical are proud to be representing this global manufacturing business in their search for a Quality Engineer to work at their facility based near Runcorn Performance Objectives To actively participate in the development of the Runcorn site Quality System (QS) in support of design control development of drug injection devices; T provide QA support for the evaluation laboratory, development workshop and design and development teams as required; To execute and follow up of internal and external CMO audits. Travel as required; To assist in selection and qualification of device CMOs. Negotiate quality agreements with CMO's as needed; To participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports; To actively participate in the compilation, review and auditing of Design History Files - both internal and external. To compile training material and conducting training sessions on quality protocols internally/externally; To liaise as needed with other sites to assure compliance with combination product regulations. Gap analysis activities both internal and external; To assist in tabulation and evaluation of data concerning quality and reliability; To participate in Corrective Action / Preventive Action (CAPA) initiatives; To oversee Continuous Improvement activities in the device suppliers. Person Specification Must have a degree in a relevant Engineering or Science discipline; Working experience in the medical devices/ pharmaceutical combination products or other FDA regulated (GMP) industry; Working experience of GMP Quality Systems and related requirements; Previous experience on design development teams is highly desirable; Audit management experience with both CMO's and internal customers; FMEA/risk analysis highly desirable; Injection moulding experience is highly desirable; Working knowledge of medical device regulatory requirements (US, Canada and Europe) highly desirable; Must be a self-starter with excellent interpersonal skills. Apply Please send your CV and call Charlotte at gap technical on 01925 406 525 If you have any questions or are interested in any other opportunities we may have, please do not hesitate to contact on 01925 406 525 This vacancy is being advertised on behalf of gap technical who are operating as an employment agency. gap technical are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability or the job. Closing date: 4/11/2016 This job was originally posted as www.totaljobs.com/job/66826812