Quality System Manager (12 month FTC)
At Eakin Healthcare we put our patient at the heart of everything we do.
Fifty years ago, it all started with one man’s mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive® seal.
Fast forward to today, and we’re still keeping it in the family. We’ve grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. We’re making a difference in three therapeutic areas:
- Ostomy
- Respiratory
- Surgical
We’re proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium and Luxemburg.
We’re good at what we do – come and join us and you can benefit from:
- Blended Working
- Bonus
- 25 days holiday plus bank holidays (rising to 28)
- Option to buy holiday days
- Wellbeing Programme
- Health Cash Plan
- Pension
- Life Assurance
- Enhanced Maternity/Paternity
- Cycle to Work Scheme
- Referral Scheme
- Long Service Awards
- Free Parking
ABOUT THE ROLE
Reporting to the Head of Group Operations Compliance, the Quality System Manager will be based at one of our manufacturing sites and will oversee and facilitate the Group eQMS and Change Control process across Eakin Healthcare Group businesses and related therapeutic areas.
Cardiff, Wales site – Pelican Healthcare Ltd & Respond Healthcare Ltd (Ostomy) and Eakin Surgical Ltd (Surgical).
Coleraine, Northern Ireland Site – Armstrong Medical Ltd (Respiratory)
Comber, Northern Ireland Site – TG Eakin Ltd (Ostomy).
The Quality System Manager plays a key role in the success of EHG’s Quality Strategy, ensuring the development and implementation of the Quality Assurance strategy while reporting on all aspects of the Quality Management System.
KEY ACTIVITIES
- Manage a team of QMS Co-Ordinators who facilitate and support Eakin Healthcare QMS using the eQMS
- Chair and facilitate the Group Change Control Program, in line with business procedural requirements
- Support New Product Development activities as required
- Lead & Professionally represent at all external agency & customer inspections
- In conjunction with the Quality & 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
- As a member of the Group Operations Compliance Team, 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
- Measure and trend Documentation and Change Control Programs against agreed
- Update and report on Eakin Healthcare Quality Scorecard matters quarterly
- Provide reports on agreed frequency on all matters associated with role to the Head of Group Operations Compliance
Other
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
- To adhere to the company’s Quality policy and Environmental policy
- To undertake other duties as may be reasonably required
KEY SKILLS
Essential
- Significant experience in a similar Quality Engineer 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
- Significantly 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 eQMS
- Microsoft Office, Excel, Word, PowerPoint and Visio
- Full UK Driving Licence
Desirable
- Educated to degree level
- Line Management experience
- Understanding of ISO 13485, ISO 14971, ISO11135, EN980 MDD 93/42/EEC and MDR 2017/45
- Methodical, with analytical and problem-solving skills and an understanding of measurement principles and techniques
KEY WORKING RELATIONSHIPS
Internal
- Operations
- Finance
- R&D
- Regulatory
- Commercial
External
- Project Team member
- Suppliers / Customers
- Notified Body
ADDITIONAL INFORMATION
- This role is responsible for 1 x Direct Report based in Cardiff
- Occasional travel to other Eakin sites as and when required
- 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
COMPETENCIES
Balances Stakeholders
Anticipating and balancing the needs of multiple stakeholders.
Directs Work
Providing direction, delegating, and removing obstacles to get work done.
Ensures Accountability
Holding self and others accountable to meet commitments.
Drives Results
Consistently achieving results, even under tough circumstances.
Manages Conflict
Handling conflict situations effectively, with a minimum of noise.
Builds Effective Teams
Building strong-identity teams that apply their diverse skills and perspectives to achieve common goals.
Communicates Effectively
Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Instils Trust
Gaining the confidence and trust of others through honesty, integrity, and authenticity.
