Quality Engineer

CooperVision Limited; Fareham; On-site; GBP 35,000 - 45,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Access to Wellness Platform

Job summary

CooperVision Limited is seeking a Quality Engineer in Fareham to ensure that all distribution operations meet quality system requirements. This role involves process validation, risk management, and improving product quality through data analysis.

The successful candidate will work closely with engineers to support validation efforts and lead CAPA investigations. Competitive compensation, benefits including 25 days holiday, and opportunities for professional development are offered.

Qualifications

• Involvement in planning and preparation of validation activities.
• Working with engineers on preparation of protocols.
• Assist in execution of qualifications to ensure product quality.

Responsibilities

• Lead risk management for local changes.
• Provide quality support for internal and external audits.
• Review and approve quality workflows in eQMS.

Skills

Excellent written and verbal communication skills

Excellent organisational skills

Knowledge of GMP / ISO 13485 / FDA QSR regulations

Computer literate

Ability to work effectively alone or in a team

Flexibility to work across UK sites

Education

Educated to degree level

3 years QA experience in a regulated industry

Job description

Job title: Quality Engineer

Department: Quality, Distribution

Location: Fareham, Hampshire

Working Hours: Mon – Fri, 37.5 hours per week

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.

Job Summary

Being part of a small team to ensure that all activities within Delta Park Distribution Operations and associated support functions meet the requirements of the Quality System and to improve the outgoing quality of Delta Park using data analysis. This role is supporting process validation, risk management and the change management processes. This role will be part of the Packaging and Distribution Quality Engineering Team and will be based at Delta Park (Fareham) with one day per week travel to Mountpark (Eastleigh) to work with the wider team.

Essential Functions & Accountabilities

Process Validation

• Involvement in the planning and preparation of projects which require validation activities
• Working with engineers in the preparation of protocols.
• Assist in the execution of installation, operational and performance qualification to ensure that equipment is performing satisfactorily and the required product quality is being achieved.

Risk Management

• Be the risk management lead in local changes and subject matter expert for Quality.
• Assist Production Engineers and change leaders in ensuring the correct evaluation of processes against existing FMEA’s documents and managing updates to documents when required.

Quality Data Trending

• Liaising with various team members to provide solutions to quality-based issues.
• Proactively leading project groups to improve the quality of products / processes.
• Monitoring processes and reporting on trends.

New Product / Process Introduction

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

Change Management

• Assisting engineers and change leaders to ensure changes are implemented in accordance with the CooperVision change management processes.
• Understanding regulatory documentation to support Production Engineers and change leaders.

Internal / External Audits

• Provide Quality Support for Internal and External Audits.
• Carry out Internal and External Audits.

CAPA

• Working with CAPA leaders to ensure quality issues are investigated in a timely manner, and appropriate corrective and preventative actions are implemented.
• Attending the CAPA Review Board.
• Leading CAPA’s when required.

Agile

• Reviewing and approving quality workflows in eQMS including validations.
• Supporting the training of the wider teams in eQMS workflows including CAPA and Validation.

Any other duties as directed by QA Management

Travel Requirements

Travel requirements may require travel to other Global sites at about 5 %.

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills.
• Excellent organisational skills.
• Working knowledge of GMP / ISO 13485 / FDA QSR regulations.
• Knowledge of and experience of using ISO 14971 Risk Management for Medical Devices or similar Risk Management process.
• Computer literate, with intermediate skill in the use of Word, Excel and Outlook.
• Ability to work effectively either alone or as part of a team.
• Ability to prioritise workload as appropriate.
• Flexibility to work across the UK sites, with some travel to suppliers and European CooperVision sites.
• Full, current driving license.

Work Environment

• The post operates primarily in a office close to the warehouse environment.
• The work environment can be noisy.
• Some areas of operations will require personal protective equipment to be worn (e.g. high visibility vest and safety footwear) – provided by the company.

Experience and Education

• Minimum of 3 years’ QA experience in a regulated industry.
• Knowledge of Contact Lens and /or Distribution processes.
• Knowledge of Lean Manufacturing and / or Six Sigma methodology.
• Completed auditor training.
• Experience of writing, approving or managing validation protocols and reports.
• Educated to degree level and / or relevant experience in a similar environment.

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 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’ll 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’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.