Quality Engineer

Job title: Quality Engineer
Department: Quality Assurance
Location: Eastleigh Hampshire / Fareham Hampshire
Working Hours: Mon-Fri 37.5 hours per week (Onsite)

A brighter future awaits you

CooperVision is one of the worlds 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. Its more than makingcontact lenses its about giving lens wearers freedom andconfidence to move about their daily lives. Were all about bright futures for our people and those who wear our contact lenses.

Job Summary:

The role of a Quality Engineer is to ensure that all activities within our Mountpark (Eastleigh) & Delta Park (Fareham) sties meet the requirements of the Quality System and to improve the outgoing quality of Mountpark & Delta Park through the use of data analysis. This role is supporting process validation risk management and the change management processes.

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 using a risk-based methodology
• Development of and manage updates to the Master Process Risk Assessments

Quality Data Trending & Process Capability

• Data analysis of production lines and liaising with Production Engineers 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 CAPAs when required

Agile

• Reviewing and approving quality workflows in Agile eQMS including validations.

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
• 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 production / 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 Packaging & 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:

Youll 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 well 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 youll 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.

If you like what you see take the first step towards your Brighter Future and apply today!All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page at view all other opportunities.

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