Senior Quality Engineer

CooperVision; Fareham; On-site; GBP 40,000 - GBP 55,000; Full time

Job summary

A leading contact lens manufacturer seeks a Senior Quality Engineer to ensure all new products and processes meet rigorous quality standards. The role involves supporting R&D and manufacturing while leading quality initiatives and continuous improvement projects. Candidates should have a Bachelor's degree, 5+ years of relevant experience, and familiarity with quality systems, statistical tools, and regulatory requirements. This position offers competitive compensation and growth opportunities within a diverse and inclusive workplace.

Benefits

25 days holiday

Pension scheme

Access to wellness platform

Discounted contact lens scheme

Qualifications

• 5+ years of experience in QA or manufacturing, preferably in contact lenses.
• Knowledge of Lean Manufacturing and/or Six Sigma methodology.
• Strong familiarity with regulatory and GMP requirements.

Responsibilities

• Ensure introduction of new projects meets quality standards.
• Provide technical support to product and process development.
• Review and approve process validation activities.

Skills

Strong communicator

Quality management

Statistical analysis

Project management

Education

Bachelor's degree in engineering or science

Tools

eQMS systems

SPC

Job description

Job Title: Senior Quality Engineer (6 Month FTC/Secondment)

Location: Mountpark, Eastleigh, Hampshire

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

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 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.

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 of 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 approval of 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 approval of Engineering studies and reports.
• Review and approval of 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.
• 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 Change Orders (ECO).
• Conduct 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.
• Understand the elements of software validation and identify processes/systems requiring software validation.
• Support preparation of documentation for regulatory submissions required of changes.
• 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 that all activities performed are in accordance with the 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 priority for the role, but the individual will need to influence and negotiate with other team members.
• Highly motivated, self‑starter, responsible, proactive, self‑directed and with the initiative to develop and implement new concepts.
• Excellent planning and organisational skills; able to manage multiple projects and prioritise complex work using effective time management.
• Uses rigorous logic and methods to solve difficult problems with practical, implementable solutions and ability to read and understand technical material.
• Demonstrates effective use of written and verbal communication skills to meet job requirements, including clear and concise writing and speaking.
• Knowledge of and experience with Quality Systems and the eQMS system, and familiarity with FDA and 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 wearing appropriate gowning.
• Flexibility of location (any Company site).

Experience and Education

• Preferably five years contact lens or process knowledge in QA or manufacturing.
• Knowledge of Lean Manufacturing and/or Six Sigma methodology.
• Strong grasp of regulatory and GMP requirements; FDA knowledge a distinct advantage.
• Bachelor’s degree in engineering, science or related field, or proven quality background – ideally five years in the medical or life sciences sectors.
• Current driving licence.

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 mental health and wellbeing, a discounted contact lens scheme and much more! We are committed to employees’ personal and professional development and offer extensive training to support career growth. 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 develop 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.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

View our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.

If you like what you see, take the first step towards your Brighter Future and apply today!