Quality Engineering Specialist

CooperVision Limited; Southampton; On-site; GBP 45,000 - 60,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Healthcare cover

Life assurance

Wellness platform

LinkedIn Learning access

Discounted contact lens scheme

Job summary

CooperVision is seeking a Quality Engineer to join the Quality team in Southampton. The role focuses on ensuring new projects meet QMS requirements and improving product quality through data analysis and continuous improvement initiatives.

You will work with UKM units, support CAPA/NCR investigations, manage risk assessments (FMEA), and assist with ECO/change management. A strong regulatory background and collaborative approach are essential.

Qualifications

• Strong knowledge of QMS, FDA, MDR and GMP/QSR requirements.
• Applied data analysis and statistical quality tools like SPC.
• Excellent planning, organization and time management to manage multiple projects.

Responsibilities

• Involve in new product/process introduction ensuring QMS requirements.
• Support process validation activities and prepare validation plans/protocols/reports.
• Lead data trending, monitor trends, and drive CAPA/NCR investigations.
• Support ECO/Change Management and training for risk management processes.
• Ensure audit readiness in line with regulatory requirements.

Skills

QMS knowledge

Data analysis

Problem solving

Communication skills

Regulatory knowledge

Education

Degree in engineering or science

Tools

MS Excel

QMS software

Job description

Southampton, Hampshire, United Kingdom (Sur site)

Job Description

Job title: Quality Engineering Speialist

Department: Quality

Location: Hamble, (Onsite)

GLS: T02

Working hours: Mon – Fri 37.5 hours a week

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 improvethe way people see each day. It’s more than makingcontact lenses, it’s about giving lens wearers freedom andconfidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

Job summary – What to expect:

Reporting to the Quality Engineering Manager, the Quality Engineer is responsible for ensuring all new projects meet Quality Management System (QMS) requirements and for improving product quality through data analysis and continuous improvement initiatives. The Quality Engineer serves as the main point of contact for quality and compliance activities, supporting UKM Business Units in all manufacturing quality matters. Working collaboratively within the quality team, they maintain and enhance QMS procedures and processes, promote best practices, and drive continuous improvement projects to improve overall quality performance.

Your responsibilities will include:

New Product/Process Introduction:

Involvement in project teams in the development and introduction of new products and processes.

Working with the project teams to ensure they meet the requirements of the Quality Management Systems.

Process Validation:

Involvement in the planning and preparation of projects which require process validation Activities.

Working with the UKM Production/Project engineer’s and support departments (e.g. facilities) in the preparation of validation plans, protocols and reports.

Support the training of the CooperVision validation process.

Assist Production/Project Engineers and support departments in ensuring that the correct evaluation of the processes risks, using a risk based (FMEA) approach.

Support the training of the CooperVision Risk Management/FMEA process.

As a designated change Assessor for the UKM, involvement in the planning and the preparation of Engineering changes orders (ECO) within UKM.

Support the training of the CooperVision ECO/Change Management Process.

Quality Data Trending & Process Capability:

Data Analysis of the production lines and liaising with the production/project engineers and support departments to provide solutions to quality-based issues.

Proactive approach to leading projects groups using structured problem-solving approach to improve the quality of the products/process.

Monitoring the processes and reporting on trends.

Working with the wider quality team to ensure compliance with Laws & Regulations such as FDA and Medical Device Regulations (MDR) to ensure BU(s) are always in an ‘audit ready’ state.

Support both CAPA and NCR teams in the investigation and determination of root cause. Evaluating preventive actions have taken place.

Any other duties as directed by the QA Management.

A full job description is available upon request.

Experience & Education:

• Strong communication and influencing skills, with the ability to promote quality best practices and achieve objectives through collaboration.
• Self-motivated and proactive, with the initiative to drive improvements and see projects through to completion.
• Excellent planning, organisation, and time management skills, with the ability to manage multiple priorities and projects effectively.
• Knowledge and experience of Quality Management Systems (QMS), including FDA, MDR, and GMP/QSR requirements.
• Applied knowledge of statistical quality tools, including SPC and Acceptance Sampling.
• Ability to interpret technical documentation and analyse data to support quality improvements.
• Proficient in Microsoft Office applications.

Two years contact lens or process knowledge in QA, and / or manufacturing.

Knowledge of Lean Manufacturing and/or Six Sigma methodology.

Strong, current grasp of regulatory and GMP requirements - knowledge of FDA and Mdr processes specifically would be a distinct advantage.

Educated to degree level and/or relevant experience in a similar manufacturing environment

Current driving license.

What we offer:

You will receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, healthcare cover, life assurance, 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 will 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 will 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.

• Locations Ensign Way, Southampton, Hampshire, SO31 4RF, GB (Sur site)

Ensign Way, Southampton, Hampshire, SO31 4RF, GB