- 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
- 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
- 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
- Involvement in project teams for the development and introduction of new products / processes
- 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
- Provide Quality Support for Internal and External Audits
- Carry out internal and external audits
- 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 CAPA's when required
- Reviewing and approving quality workflows in Agile eQMS including validations.
- 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 (. high visibility vest and safety footwear) – provided by the company
- Travel requirements may require travel to other Global sites at about 5 %.
- Educated to degree level and / or relevant experience in a similar environment.
- 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.
- 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.
- Flexibility to work across the UK sites, with some travel to suppliers and European CooperVision sites.
- Full, current driving license.
Senior Quality Assurance Engineer - Eastleigh, United Kingdom - CooperCompanies
Description
JOB TITLE : Quality Assurance Engineer
LOCATION : Mount Park, Eastleigh
WORKING HOURS : 37.5, Monday to Friday
A brighter future awaits you
At CooperVision, we are proud to be the global leader in contact lenses. At our innovative sites worldwide, we manufacture and distribute contact lenses to some of the biggest names in optics. We're all about creating brighter futures for our customers, our wearers and our people.
What can you expect from us as an employer? Well, we like to look at things a little differently. We call it bringing a refreshing perspective. And for every one of us who works here, it means our opinion really counts, we get to share our ideas, and we get to make an impact.
We're big on belonging. Because being part of something great is what makes our company the best it can be. And we value diversity, because you can see a whole lot more when you have different perspectives. We're an ambitious company. And to help us achieve our goals, we'll give you all you need to achieve yours.
What will you be doing:
As a Quality Assurance Engineer, you will be working within a small team to ensure that all activities within Mount Park and Delta Park meet the requirements of the Quality System and to improve the outgoing quality of Mount Park and Delta Park through the use of data analysis.
This role will also be supporting process validation, risk management and the change management process.
Essential responsibilities:
Process Validation
Risk Management
Quality Data Trending & Process Capability
New Product / Process Introduction
Change Management
Internal / External Audits
CAPA
Agile
Work Environment:
Travel Requirements :
What are we looking for?
In addition, you'll have experience in:
What we offer
You'll 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