Quality Engineer

CooperVision; Fareham; On-site; GBP 42,000 - 58,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Wellness Platform

Discounted contact lens scheme

LinkedIn Learning

Job summary

CooperVision in Fareham, Hampshire, seeks a Quality Engineer to join the Packaging and Distribution Quality Engineering Team. You will ensure that all activities meet the Quality System requirements and improve the outgoing quality using data analysis.

Based at Delta Park (Fareham) with one day per week travel to Mountpark (Eastleigh) to collaborate with the wider team, you will support process validation, risk management and change control.

Qualifications

• Minimum 3 years QA experience in a regulated industry.
• Knowledge of contact lens and/or distribution processes.
• Experience with validation protocols and reports.

Responsibilities

• Validate and mirror quality systems to ensure product quality.
• Lead CAPA activities and drive corrective actions.
• Support internal/external audits and risk management.
• Monitor quality data trends and report findings.

Skills

Communication skills

Organisational skills

GMP knowledge

ISO 13485 knowledge

FDA QSR knowledge

ISO 14971 knowledge

Word, Excel, Outlook

Teamwork

Prioritisation

UK site mobility

Driving licence

Education

Degree level education

Auditor training

Tools

eQMS

Job description

Location: Fareham, Hampshire

Working Hours: Mon – Fri, 37.5 hours per week

Job Title: Quality Engineer

Department: Quality, Distribution

Job Summary: Ensure that all activities within Delta Park Distribution Operations and associated support functions meet the requirements of the Quality System and improve the outgoing quality of Delta Park using data analysis. Support process validation, risk management, and change management processes. The role is 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 for local changes and a subject matter expert for Quality
• Assist Production Engineers and change leaders in evaluating processes against existing FMEA documents and managing updates when required

Quality Data Trending

• Liaise with various team members to provide solutions to quality-based issues
• Proactively lead project groups to improve the quality of products and processes
• Monitor processes and report on trends

New Product / Process Introduction

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

Change Management

• Assist engineers and change leaders to implement changes in accordance with the CooperVision change management processes
• Understand 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

• Work with CAPA leaders to ensure quality issues are investigated in a timely manner and appropriate corrective and preventative actions are implemented
• Attend the CAPA Review Board
• Lead CAPAs when required

Agile

• Review and approve quality workflows in eQMS including validations
• Support the training of the wider teams in eQMS workflows including CAPA and validation

Travel Requirements

Travel may be required 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 and FDA QSR regulations
• Knowledge of ISO 14971 Risk Management for Medical Devices or a similar process
• Computer literacy with intermediate skill in 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 UK sites, with some travel to suppliers and European CooperVision sites
• Full, current driving licence

Work Environment

• The post operates primarily in an office close to the warehouse environment
• The work environment can be noisy
• Some areas of operations 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 writing, approving or managing validation protocols and reports
• Degree level education and/or relevant experience in a similar environment

What we offer

Competitive compensation and a benefits package including 25 days holiday, pension scheme, access to our Wellness Platform, a discounted contact lens scheme and more. Extensive training and development opportunities, including access to LinkedIn Learning.

What you can expect

As a CooperVision employee you will be welcomed into a diverse and progressive global business and will have opportunities for personal and professional development.

All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.