About Us
Eakin Healthcare is a company that puts its patients at the heart of everything it does. Our journey began fifty years ago when pharmacist Tom George Eakin saw his patients struggling with leaking urostomy pouches and decided to take action. He formulated what would become the game-changing Eakin Cohesive seal, which revolutionized the industry.
Today, we are still committed to our mission and have grown significantly since our inception. We now have a team of over 700 colleagues across three manufacturing sites and twelve sales and distribution centers. We export our innovative products to over sixty countries through a network of forty distributors and our own offices in Japan, the Netherlands, France, Germany, Belgium, and Luxembourg.
We are proud of our achievements and offer a range of benefits to our employees, including blended working, bonus schemes, and a wellbeing program.
Role Overview
The Quality System Manager will be responsible for overseeing and facilitating the Group e QMS and Change Control process across Eakin Healthcare Group businesses and related therapeutic areas. This role will play a key part in the success of EHGs Quality Strategy, ensuring the development and implementation of the Quality Assurance strategy while reporting on all aspects of the Quality Management System.
Key Responsibilities
* Manage a team of QMS Co-Ordinators who facilitate and support Eakin Healthcare QMS using the e QMS
* Chair and facilitate the Group Change Control Program, in line with business procedural requirements
* Support New Product Development activities as required
* Lead and professionally represent at all external agency and customer inspections
* In conjunction with the Quality and Regulatory Department, provide input, support, and collaborative decisions regarding the execution of any Field Safety Corrective Actions (FSCA) in a timely, thorough, and transparent manner
* Deliver relevant Internal quality assurance training for departments
* Develop and implement a system for imbedding QA culture through the UK Businesses
* Responsible for ensuring the Quality Management System is maintained to deliver compliance and aligns with assigned KPI
* Support both the Internal and Supplier audit schedule, conducting Inspections when assigned
* Work on cross-functional teams providing input when required
* Contribute to budget preparations in conjunction with Head of Group Operations Compliance
* Ensure that all assigned budgets are monitored and delivered
Key Skills
* Significant experience in a similar Quality System Manager role
* Quality Compliance experience in a Medical Device customer-driven environment
* Experience in Medical Device or IVD environment working to ISO Standards and FDA CFR in a continuous improvement environment
* Strong communication skills, both verbal and written
* An organised individual who has the ability to assess priorities based upon the wider business demands
* Ability to work as part of a team
* SME for e QMS
* M Microsoft Office, Excel, Word, Power Point and Visio
* Full UK Driving Licence
This role is a 12-month fixed-term contract covering maternity leave and can be based at one of our manufacturing sites in either Cardiff, Comber, or Coleraine.