Quality Engineer

Job DescriptionJob title: Quality EngineerDepartment: Quality AssuranceLocation: Eastleigh, Hampshire / Fareham, HampshireWorking Hours: Mon-Fri, 37.5 hours per week (Onsite)A brighter future awaits youCooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.Job Summary:The role of a Quality Engineer is to ensure that all activities within our Mountpark (Eastleigh) & Delta Park (Fareham) sties meet the requirements of the Quality System and to improve the outgoing quality of Mountpark & Delta Park through the use of data analysis. This role is supporting process validation, risk management and the change management processes.Essential Functions & Accountabilities:Process ValidationInvolvement in the planning and preparation of projects which require validation activitiesWorking with engineers in the preparation of protocolsAssist in the execution of installation, operational and performance qualification to ensure that equipment is performing satisfactorily, and the required product quality is being achievedRisk ManagementBe the risk management lead in local changes and subject matter expert for QualityAssist Production Engineers and change leaders in ensuring the correct evaluation of processes using a risk-based methodologyDevelopment of and manage updates to the Master Process Risk AssessmentsQuality Data Trending & Process CapabilityData analysis of production lines and liaising with Production Engineers to provide solutions to quality-based issuesProactively leading project groups to improve the quality of products / processesMonitoring processes and reporting on trendsNew Product / Process IntroductionInvolvement in project teams for the development and introduction of new products / processesChange ManagementAssisting engineers and change leaders to ensure changes are implemented in accordance with the CooperVision change management processesUnderstanding regulatory documentation to support Production Engineers and change leadersInternal / External AuditsProvide Quality Support for Internal and External AuditsCarry out internal and external auditsCAPAWorking with CAPA leaders to ensure quality issues are investigated in a timely manner, and appropriate corrective and preventative actions are implementedAttending the CAPA Review BoardLeading CAPA’s when requiredAgileReviewing and approving quality workflows in Agile eQMS including validations.Travel RequirementsTravel requirements may require travel to other Global sites at about 5 %.Knowledge, Skills And AbilitiesExcellent written and verbal communication skills.Excellent organisational skills.Working knowledge of GMP / ISO 13485 / FDA QSR regulationsKnowledge of and experience of using ISO 14971 Risk Management for Medical DevicesComputer literate, with intermediate skill in the use of Word, Excel and Outlook.Ability to work effectively either alone or as part of a team.Ability to prioritise workload as appropriate.Flexibility to work across the UK sites, with some travel to suppliers and European CooperVision sites.Full, current driving license.Work Environment The post operates primarily in a production / warehouse environment The work environment can be noisy Some areas of operations will require personal protective equipment to be worn (e.g. high visibility vest and safety footwear) – provided by the company Experience And EducationMinimum of 3 years’ QA experience in a regulated industryKnowledge of Contact Lens and /or Packaging & Distribution processesKnowledge of Lean Manufacturing and / or Six Sigma methodologyCompleted auditor trainingExperience of writing, approving or managing validation protocols and reportsEducated to degree level and / or relevant experience in a similar environmentWhat we offer:You’ll receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much moreWe are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVisionWhat you can expect:As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.If you like what you see, take the first step towards your Brighter Future and apply today All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.