Job title: Quality Affairs/Regulatory Compliance Director
Department: Commercial
Location: Hamble, Southampton (on site role)
GLS: M05
Working hours: Monday – Friday / 8:30 – 4:30
A brighter future awaits you
CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.
Job summary – What to expect:
As the QA/RC Director you will be responsible for the development and strategic leadership of the Quality Assurance Function, Quality Management System Compliance, Quality Engineering, and Quality Control for UK manufacturing. You will be a key part of the UKM Senior Manager Team overseeing sites that operate world-class technology in a 24/7 high volume facility, responsible for setting strategic goals aligned with the Global CooperVision objectives and long-term strategic plan.
This is a fantastic opportunity to shape the future of the team.
Lead the QA department to ensure manufacturing processes produce contact lenses that meet CooperVision’s specifications, customer and external regulatory requirements To head and oversee all 3rd party audits and inspections and ensure adequate resources are available to support each internal and external audit. Responsible for ensuring all contact lenses meet the required release criteria including sterility, safety, efficacy and labelling Devise meaningful and clear metrics for the QA department's performance in line with the Business Goals and Global scorecard. To continually develop the capability of the QA function and ensure that talent management and succession planning provide for the future needs of the business. Be the lead and point of contact for any issues of product quality related to UK-manufactured products. In close collaboration with the global QA team, ensure quick decisions and actions are taken. Ensure effective escalation management and tool use for corrective and preventive activities, including NCR, CAPA, HHE, and audit.A full job description is available upon request.
About you:
We are looking for an experienced leader who has a proven track record operating at a strategic level to ensure correct management of quality processes and techniques. You should be able to prioritise the connection to the business including Engineering and Manufacturing teams in order to achieve business results. You should have experience developing a team and communicating a strategy to inspire and motivate teams towards success.
Experience & Education:
Extensive knowledge and the practical application of ISO Standards applicable for the manufacture of medical devices and EU MDD/MDR, USA QSR and MDSAP Extensive experience in quality improvement processes and techniques (e.g. Six Sigma, Statistical Process Control, Structured Problem Solving, LEAN) Extensive experience of management and ownership of complex problem resolution including CAPA, 3rd party inspections including FDA responses to inspection finding and deficiencies. Proven capability to develop high performing teams and maintain a culture of Quality and Continuous Improvement. Manufacturing experience in medical devices or other regulated industry. Preferred degree in Engineering or related science / advanced degree highly desirable.What we offer:
You’ll receive competitive compensation and a fantastic benefits package including; competitive salary, annual bonus. car allowance, private medical insurance – 25 days holiday, 9% 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!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in you career and grow with CooperVision
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.
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.
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