Quality Improver

CooperVision; Southampton; On-site; GBP 42,000 - 60,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Healthcare cover

Life assurance

Wellness Platform

Discounted contact lens scheme

Job summary

CooperVision is a world-leading contact lens manufacturer with a presence in over 100 countries. This role focuses on leading quality investigations across the Packaging and Distribution Group, ensuring timely completion, root cause analysis, and effective CAPA actions, while maintaining regulatory and Quality System compliance.

You will drive continuous improvement with cross-functional teams, lead QA in NCRs, complaints and SNC investigations, and support risk assessments, change management,

Responsibilities

• Represent QA in NCR, Quality Feedback, Customer Complaint and SNC investigations
• Perform root cause analysis and train others outside QA
• Monitor time to complete investigations to minimise customer impact
• Complete investigation reports individually and with teams, lead meetings
• Evaluate effectiveness of corrective and preventative actions
• Lead and participate in quality improvement projects
• Develop documentation for improvement projects including training material
• Provide training to meet project requirements
• Risk assessment lead and SME for Quality
• ECO Leader and ECO Change Analyst
• Support Engineering team and wider business with changes
• Identify Corrections, Corrective Actions and Preventive Actions within CAPA teams
• Ensure quality issues are investigated in a timely manner and actions implemented
• Review metrics for NCRs, Customer Complaints, QFBs and SNCs
• Provide GMP training and represent QA in GMP improvement projects
• Create procedures and work instructions
• Other duties as directed by QA Management

Skills

Root cause analysis

Quality investigations

Cross-functional collaboration

Training others

GMP knowledge

Data trending

Documentation

Project/Change management

ISO14971 knowledge

ISO13485 knowledge

Tools

GPS

Baan

Red Prairie

Agile

Microsoft Office

Job description

Lead quality investigations across the Packaging and Distribution Group, ensuring compliance with company procedures, timely completion, accurate root cause analysis, and effective corrective and preventive actions. Working with cross-functional teams, drive continuous improvement initiatives, lead quality improvement projects, and support compliance with regulatory and Quality System requirements across all business units.

NCR / Quality Feedback / Complaints / SNC

• Representing QA in NCR, Quality Feedback, Customer Complaint and SNC investigations
• Performing root cause analysis and training this concept to others outside of the QA group
• Monitoring the time taken to complete investigations with the aim of minimising customer impact
• Completing investigation reports individually and with teams, leading meetings where appropriate
• Evaluating effectiveness of corrective and preventative actions

Quality Improvement / Continuous Improvement

• Leading and participating in project groups to improve the quality of products / processes
• Developing supporting documentation for improvement projects including training material
• Providing training to meet project requirements

Risk Assessment

• Risk Assessment Lead
• Risk Assessment Team member and Subject Matter Expert for Quality

Change Management

• ECO Leader
• ECO Change Analyst
• Support Engineering team and wider business with changes

CAPA Leader

• Identifying Corrections, Corrective Actions and Preventive Actions within CAPA teams
• Working with CAPA leaders to ensure quality issues are investigated in a timely manner, and appropriate corrective and preventative actions are implemented

Quality Data Trending

• Review metrics where applicable to monitor performance of Quality processes, such as NCR, Customer Complaints, QFBs and SNCs

GMP

• Providing GMP training
• Representing QA in GMP improvement projects

Documentation

• Technical Report writing
• Engineering Study approval
• Creating procedures and work instructions

• Any other duties as directed by QA Management
• Highly motivated and responsible.
• Good written and verbal communication skills.
• Good organisational skills.
• Ability to work effectively either alone or as part of a team.
• Ability to prioritise workload as appropriate.
• Knowledge of quality improvement tools and processes.
• Knowledge of ISO14971, Application of Risk Management to Medical Devices
• Computer literate, with knowledge of GPS, Baan, Red Prairie, Agile and Microsoft packages.
• Flexibility to work across the UK sites.
• Full, current driving license.
• Minimum of 1 years' experience in a regulated industry
• Knowledge of Contact Lens and Packaging & Distribution processes
• Experience in Quality or Engineering an advantage
• Knowledge of ISO13485 beneficial
• Knowledge of and experience of using ISO14971, Application of Risk Management to Medical Devices

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.

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!

• 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

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.