Quality Systems Engineer
Job title: Quality Systems Engineer Job type: 6 -12 months + extensions Location: Leeds, Yorkshire, North East UK Salary: �20 to �25 / hour contract rate A Quality Systems Engineer with process validation & compliance experience is required by a leading medical device company based in Leeds The ideal candidate will be responsible for the testing and validating of new and existing products, as well as process evaluation and continuous improvement In return, a salary of �20 to �25/hour is on offer, as well as the chance to work with an industry leading organisation JOB PURPOSE The Quality Systems Engineer shall lead from a Technical Quality perspective the transfer of ownership of product Design History Files between company design facilities The job holder will lead from a Technical Quality perspective by ensuring all quality and compliance requirements are available and appropriate, i.e, preparing Risk Management plans, reviewing Design Control plans and overseeing qualification & validation process where necessary. MAIN DUTIES & RESPONSIBILITIES *Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls *Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material. Manage QA related change control for specific projects as directed *Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations *Perform/document dimensional/visual inspections and non conformance and deviations as required *Manage a variable workload to meet operational requirements *Ensure that all Health, Safety and Environmental requirements are fulfilled *Risk Management oversight and review during DHF development and product life cycle phases Review & report on analysis of field inquiry reports *Ensure effective problem analysis/complaint investigation as required and define through negotiation effective corrective actions *Provide reliability objectives & assessment plans for Product Development and sustaining team *Liaise with R & D to ensure CTQs are agreed and documented for all NPD PRINCIPLE ACCOUNTABILITIES *Process Excellence - Continuous Process Improvement *Process/Quality Input for validation processes and new product introduction *Inspection of products & processes *GMP ESSENTIAL QUALIFICATIONS & EXPERIENCE *HNC or equivalent *Strong background in Quality Assurance/Engineering *Engineering qualification or similar to support functional tasks *Proven track record in Compliance & Continuous improvement projects *Proven knowledge and ability regarding product verification and process validations *Knowledge and understanding of validation techniques such as risk assessment, master validation planning, IQ, OQ, PQ, change control and process verification *Must have a full understanding of Geometric Dimensioning and Tolerancing and be fully conversant with engineering drawings DESIRABLE *Basic understanding of French Language *Process Excellence Green Belt/Black Belt *Working knowledge of Quality Systems (FDA/ISO) and MDD GMP requirements regarding medical Devices within a regulated environment For more information, a full job spec and the chance to apply, please contact James Harvey at Gold group on 01342 330 515, or send your CV to email@example.com This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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