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.
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