Quality Engineering Specialist

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
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.
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 Cooper Vision validation process.

• Risk Management/FMEA:
• 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 Cooper Vision Risk Management/FMEA process.

• Engineering change control:
• 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 Cooper Vision 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.
• Additional duties;
• 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.

• 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…