Description Job title: Quality Engineer Department: Quality Assurance Location: Eastleigh, Hampshire / Fareham, Hampshire Working Hours: Mon-Fri, 37.5 hours per week (Onsite) A brighter future awaits you CooperVision 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 Validation Involvement in the planning and preparation of projects which require validation activities Working with engineers in the preparation of protocols Assist in the execution of installation, operational and performance qualification to ensure that equipment is performing satisfactorily, and the required product quality is being achieved Risk Management Be the risk management lead in local changes and subject matter expert for Quality Assist Production Engineers and change leaders in ensuring the correct evaluation of processes using a risk-based methodology Development of and manage updates to the Master Process Risk Assessments Quality Data Trending & Process Capability Data analysis of production lines and liaising with Production Engineers to provide solutions to quality-based issues Proactively leading project groups to improve the quality of products / processes Monitoring processes and reporting on trends New Product / Process Introduction Involvement in project teams for the development and introduction of new products / processes Change Management Assisting engineers and change leaders to ensure changes are implemented in accordance with the CooperVision change management processes Understanding regulatory documentation to support Production Engineers and change leaders Internal / External Audits Provide Quality Support for Internal and External Audits Carry out internal and external audits CAPA Working with CAPA leaders to ensure quality issues are investigated in a timely manner, and appropriate corrective and preventative actions are implemented Attending the CAPA Review Board Leading CAPA’s when required Agile Reviewing and approving quality workflows in Agile eQMS including validations. Travel Requirements Travel requirements may require travel to other Global sites at about 5 %. Knowledge, Skills and Abilities Excellent written and verbal communication skills. Excellent organisational skills. Working knowledge of GMP / ISO 13485 / FDA QSR regulations Knowledge of and experience of using ISO 14971 Risk Management for Medical Devices Computer 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 Education Minimum of 3 years’ QA experience in a regulated industry Knowledge of Contact Lens and /or Packaging & Distribution processes Knowledge of Lean Manufacturing and / or Six Sigma methodology Completed auditor training Experience of writing, approving or managing validation protocols and reports Educated to degree level and / or relevant experience in a similar environment What 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 more! We 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 CooperVision What 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. LI-ONSITE LI-JH1