Job Title: Senior Quality Engineer (6 Month FTC/Secondment)
Location: Mountpark, Eastleigh, 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.
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 principal 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.
Essential Functions & Accountabilities
* 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 quality/statistical tools for troubleshooting and identification of product and process improvement.
* Evaluate process changes for potential impact on the business and recommend 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 approve Process Validation activities such as IQ, OQ and PQ protocols and reports as required by the project team, including NCR and Deviations process during the execution of the project.
* Review and update SOPs and project related documentation.
* Perform eQMS document submission (DCR, DCO, ECO, QP, APP, etc.).
* Assist in developing and executing and reporting of Engineering Studies for product and process characterisation and development.
* Review and approve Engineering studies and reports.
* Review and approve FAT and SAT documents.
* Actively participate 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 contribute to projects activities such 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).
* Conduct NCR/Quality Issue investigations related to projects in conjunction with the BU and liaise 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 participate and support in the documentation preparation for Regulatory Submissions required of changes.
* Participate and support Regulatory Agency Inspections of the facilities and ensure corrective actions are performed as required.
* Create a culture of quality awareness, teamwork and cooperation with all groups and within the facility.
* Oversee and provide guidance to ensure all activities performed are in accordance with Quality System and regulatory requirements to be in an *Audit Ready* state.
Travel Requirements
* Travel to other domestic and international CooperVision sites (5%).
Knowledge, Skills And Abilities
* A strong driver, communicator and influencer; Quality is a top agenda, impacting interaction with team members.
* Highly motivated, self‑starter, proactive, and responsible.
* Excellent planning and organisational skills; able to manage multiple, complex projects with effective time management.
* Uses rigorous logic and methods to solve difficult problems with implementable solutions and the ability to understand technical material.
* Demonstrates effective written and verbal communication skills to meet job requirements, including clear, succinct writing and speaking.
* Knowledge of Quality Systems and eQMS, FDA and other current standards/regulations.
* Applied knowledge of statistical tools: Acceptance Sampling, SPC, etc.
Work Environment
* The role operates in an office environment but may involve entering ASEC areas and being gowned up.
* Flexibility of location across any Company site.
Experience And Education
* Preferably five years contact lens or process knowledge in QA and/or manufacturing.
* Knowledge of Lean Manufacturing and/or Six Sigma methodology.
* Strong grasp of regulatory and GMP requirements – FDA processes knowledge is a distinct advantage.
* Bachelor’s degree in Engineering, Science or related field or proven Quality background – ideally five years’ experience in medical or life sciences sectors.
* Current driving license.
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 your 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 reach their full potential. We also provide access to LinkedIn Learning.
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.
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