Quality Engineer

Job title:

Quality Engineer Department:
Quality, Distribution

Location:

Fareham, Hampshire

Working Hours:

Mon – Fri, 37.5 hours per weekA brighter future awaits youCooper

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:

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 Cooper Vision 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.

CAPAWorking 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

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 Cooper Vision sites.

Full, current driving license.

Excellent written and verbal communication skills.

Excellent organisational skills.

Computer literate, with intermediate skill in the use of Word, Excel and Outlook Experience and Education Minimum of 3 years’ QA experience in a regulated industry.

Demonstrated experience of Quality Engineering, validation and risk management.

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 /…