Quality Engineer

Job Description

You will be responsible for supporting the business in delivering a safe and effective product that complies with all applicable regulatory requirements by providing Quality Assurance representation, input and oversight in the development and manufactureof devices.Client DetailsAn established global manufacturer of products that produce high-resolution images of the retina, something no other imaging device is capable of in a single comfortable capture. This combined device facilitates the early detection, management and effectivetreatment of disorders and diseases evidenced in the retina such as retinal detachments and tears, glaucoma, diabetic retinopathy, and age-related macular degeneration.Having celebrated its 30th anniversary in 2022 and is proud to be recognized as a leading provider of devices to eye care professionals to provide a more complete approach to patient care.Description* Strategically lead performance improvement projects to increase the capability of consistently meeting requirements. Projects may include process analysis, value stream mapping, process capability and throughput analysis, 6-Sigma, 5S and Kaizen events.* Lead, support, and challenge suppliers to ensure the correct quality for delivering products to the business.* Assist with the collation, review and presentation of product and QA metrics to enable feedback and support regulatory compliance.* Drive compliance by supporting internal audit process and performing internal audits as required. * Assist in the application of Optos risk assessment process to product development and change control.* Perform QA review and approval of process documentation (SOPs, WIs, Route Cards, C of C/Rs, PQ Protocols / Reports etc.)* Provide support during the preparation, hosting and follow up of 3rd party audits.* Participation in project teams as Quality Assurance representative.Profile* HNC/HND (or equivalent) in a related subject or equivalent education gained through work experience.* Knowledge and practical experience of ISO 9001/13485 system is essential.* Previous experience in a quality department or drawing office, ideally within a manufacturing environment. * Previous documentation experience in a medium/high volume manufacturing environment.* Proven ability and significant commercial awareness of FDA regulatory issues.* A mind set which continually assess performances and seeks opportunities for improvement.* Familiarity with auditing techniques.* Flexible, persistent, and pragmatic.* Technically driven with good analytical skills.* Good written and verbal communication and negotiation skills.* Strong pro-active communicator with the ability to influence others.Job Offer£38K - £45K DOEHybrid WorkingOpportunity to work with an established global manufacturer producing early detection, management and effective treatment for diseases and disorders in the retina.Excellent benefits packageInnovative and forward-thinking business

Keyskills :
ManufacturingProcess ImprovementQuality AssuranceQMSQuality EngineerISO 9001:2015QA Design & Change Controlengineering change controlISO13485 and FDA Medical Device Design Control