Quality Officer

At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries.

We’ve been recognised as a Great Place to Work®! And we’re proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women.

At Eakin Healthcare, we’re united by one mission: working together to improve lives – just like we’ve been doing for over five decades.

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
• Health Cash Plan
• Pension
• Life Assurance
• Enhanced Maternity/Paternity
• Cycle to Work Scheme
• Referral Scheme
• Long Service Awards
• Free Parking

A member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a key role in the Operations Compliance Team, provide business support and guidance in line with Compliance and Eakin Healthcare Strategies.

This role in based in Coleraine, Northern Ireland and is an excellent opportunity for an individual to work closely with both site-based functions and colleagues and wider group colleagues in the Group Operations Compliance Team.

Involved in the creation, improvement and maintenance of regulatory compliant Quality Management System (QMS) documentation (and training thereof) that will include, but not be limited to:

• QMS reports and analysis of reports for review by the Quality Manager.
• Quality reports for review at Management Review meetings.
• Reviewing and actioning feedback from customers.
• Support creation, revision and maintenance of Operating Procedures, Quality Forms and Work Instructions.
• Support QMS studies and reports e.g. stability studies.
• Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements.
• Support and execute the timely release of finished medical devices to ensure schedules are maintained and stock available.
• Support and co-ordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO
  13485, MDSAP, GMP, GDP, FDA CFR).
• Inform and collate quality feedback data ensuring that key information is relayed to the Quality Manager.
• Support and perform internal audits under guidance from the QHSE Auditor or Quality Manager.
• Assisting the Quality Manager with the achievement of annual objectives as directed.
• Collate and trend quality metrics and suggest improvement activities as required.
• Support and assist third party audits and inspections across Eakin Healthcare as required.
• Assist with ensuring the QMS reflects practice and is kept up to date in line with requirements.
• In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported within Target Closure timelines; and ensure all stability studies are documented, actioned, and reported.
• Collaborate and own Corrective and Preventative Actions, Customer Complaints, Non
  - Conformances, and subsequent product dispositions e.g. product rework administration.
• Maintain the Calibration
• Support the change control system by accurate completion of documentation and realising any relevant actions.
• Ensure product quality standards are met by implementing inspection and testing protocols on products within all production, goods in and warehousing areas
• Ensure inspections are performed in…