Senior Quality Engineer

Fareham, Hampshire, United Kingdom (On-site)

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Job title: Senior Quality Engineer

Department: Global Quality Engineering

Location: Mountpark, Eastleigh, Hampshire

Working Hours: Mon – Fri, 37.5 hours per week (Onsite)

A brighter future awaits you.

Cooper Vision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of Cooper Vision 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.

Scope:

Reporting directly to the Quality Engineering Manager, the Senior QA Engineer shall ensure that the introduction of all new projects, equipment and processes, and products within the business meet the requirements of the Quality Management System using data analysis, risk management and quality planning.

Job Summary:

The Senior Quality Engineer shall act as the principle contact for quality and compliance activities during new product introductions, new equipment and processes, quality systems as well as continuous improvement projects. The Senior QE will provide support to R&D, GTIG, PTIG and the Business Units (BUs) functions in all quality related aspects of lens development, manufacturing and subsequent secondary packaging activities to ensure best practice and standardisation opportunities across all sites are identified.

The Senior Quality Engineer, working as part of a team, shall also maintain and develop existing Quality Management System procedures and processes through monitoring and determining product and process capability and leading continuous improvement projects.

• Actively participate and assist in the development of the strategy and validation plan for the implementation of new equipment and processes, products, new technologies and continuous projects for existing processes and products.
• Provide the appropriate quality technical support to new product and process development and continuous improvement projects to ensure they meet the requirements of the Quality Management System.
• Responsible for Sampling Plan Preparation, Quality Plan/ Control Plan Development, Test procedures Implementation and Statistical Data Analysis.
• Use of quality/statistical tools for troubleshooting and identification of product and process improvement.
• Evaluate process changes for potential impact on the business and recommending their incorporation into the current and future production lines to improve product/process quality.
• Lead quality initiatives and participate in multi-disciplinary teams engaged on the above activities.
• Review and approval of Process Validation activities such as: IQ, OQ and PQ protocols and reports as required by the project team. This may include NCR and Deviations process during the execution of the project.
• Review and update SOPs and project related documentation.
• Assist in developing and execution and reporting of Engineering Studies for product and process characterisation and development.
• Review and approval of Engineering studies and reports.
• Review and approval of FAT and SAT documents.
• Actively participates in the “Design Transfer” process during product transfer from R&D into lens manufacturing facilities and subsequent design realisation through the Packaging and distribution sites.
• Actively participate in product and process site to site transfer activities.
• Actively contributes in related to projects activities as Risk Assessment and Project meetings.
• Assist Project Engineers in ensuring the correct and appropriate evaluation of the processes using a Risk based methodology.
• Involvement in the planning and preparation of Engineering Changes Orders (ECO).
• Conducting NCR/Quality Issue investigations related to project in conjunction with the BU and liaising with the BU(s) to ensure the appropriate product disposition is implemented.
• Understanding of the elements of software validation and identification of processes/systems requiring software validation.
• Actively…