Senior Quality Assurance Engineer

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

• 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 CAPA’s when required

Agile

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

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

Travel Requirements :

What are we looking for?

• 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.

In addition, you’ll have experience in:

• 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.

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!

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.

What is important to us

Our four values define and underpin our unique culture; we are dedicated , we are inventive , we are friendly , and we are partners . Becoming part of the CooperVision family means joining a friendly team that’s open, flexible, and respectful of each other’s differences, working together to achieve something amazing.

Recruiting, retaining, and promoting a diverse mix of employees is core to our success. It helps bring different perspectives, diverse conversations, and new ideas to the table, all of which are incredibly valuable.

At CooperVision we celebrate, not only our company success, but we celebrate who we all are individually, and we embrace diversity. We support and we encourage you to bring your full self and not just part of you. We are committed to each individual and we look forward to a Brighter Future together.

THIS ROLE IS OPEN TO EXTERNAL AND INTERNAL CANDIDATES. IF YOU ARE APPLYING INTERNALLY, PLEASE INFORM YOUR LINE MANAGER

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CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.
CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That’s a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and a diverse, inclusive, employee-centric culture fuel a deeply engaged, high performing organization.
CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That’s a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.