Senior Quality Systems Specialist

Job Description

JOB TITLE : Senior Quality Systems Specialist (12 month Fixed Term Contract) **

LOCATION : Hamble (Hybrid – 2 days office vs 3 at home) Remote working considered

WORKING HOURS : Monday to Friday 37.5 hours per week

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?**

We have an exciting 12 month Fixed Term Contract opportunity for a Senior Quality Systems Specialist to join our Global Quality Systems team. This is an exciting role where you will workglobally across all design & development, manufacturing, distribution, and regional locations. You will facilitate and provide support for various Global Quality System (GQS) responsibilities and objectives.

You will have a strong working understanding of medical device manufacturing quality systems and the related regulations and standards. In this role, you will work directly with R&D, manufacturing, distribution, and regional sites in the development, establishment, maintenance, and continuous improvement of the Global Quality Management System (GQMS). **

Responsibilities**

• Support and directly participate in the development, establishment, maintenance, and continuous improvement of GQMS policies, procedures, and processes.
• Coordinate and support recurring CAPA Review Board meetings for global and/or non-site quality system issues.
• Working with the global CAPA process owner and site CAPA process coordinators, lead development of CAPA investigation tools and techniques and contribute to the delivery of associated training.
• Lead and/or contribute to individual CAPA investigations, working with appropriate resources from across the global business.
• Act as global process owner for the Documents of External Origin process, ensuring that the process is established, maintained, and continuously improved. Ensure that activities required by the Documents of External Origin process are identified and tracked to completion, working with SMEs and team members from across the business.
• Provide support for the processes associated with the feedback processes of the GQMS (e.g. Complaints, NCRs, Audit findings etc.).
• Provide support for the processes associated with the Design and Change Control processes of the GQMS (e.g. ECOs, Design Controls, DCOs etc.)
• Lead and guide projects related to the GQMS, including introduction of new processes, continuous improvements, or addressing compliance related issues.
• Support GQMS projects by participating with cross-functional teams over multiple sites and time zones.
• Facilitate and track various projects in support of GQS team objectives.
• Facilitate, support, and continuously improve the global quality objectives/global quality planning/global management review system.
• Develop, establish, and continuously improve quality processes in the role of process owner, as required. As a process owner, provide stewardship over assigned processes to ensure compliant and effective quality systems and processes.
• Travel to the R&D, manufacturing, distribution, and regional locations to:
• support the GQMS and GQS projects,
• interact and build relationships with local teams,
• understand processes at the site level.

Qualifications

What are we looking for?

We would like you to have the following experience:

• 5 to 7 years of quality engineering or quality system experience working in a medical device manufacturing environment.
• 3 to 5 years of experience in the application of 21 CFR 820, ISO 13485 and MDSAP auditing approach.
• Experience in developing, analysing/trending and publishing quality system metrics.
• Experience in effectively working across multiple sites, time zones, and cultures.
• Experience with product lifecycle management (PLM) applications such as Agile Experience with business intelligence applications (ie Business Objects, Cognos, Tableau) would be ideal
• Compliance level knowledge of 21 CFR 820, ISO 13485:2016, and other applicable quality system regulations would be useful
• Knowledge of the EU Medical Devices Regulation 2017/745.
• Working knowledge of quality systems, processes, and their interactions in a medical device manufacturing environment.
• Strong knowledge of the CAPA system and utilisation of the QMS processes acting as inputs to the system.

What do we offer?

You’ll receive competitive compensation and a fantastic benefits package including; 25 days holiday, private medical, 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. **

About Us**

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.