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.

WHY JOIN US?

• 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

ABOUT THE ROLE

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 is 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.

KEY RESPONSIBILITIES

• 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 (ISO13485, 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 compliance with QMS documentation and that the inspections are being recorded accurately.
• Develop a high level of understanding of the safety and functional aspects of each product type.
• Report all Quality related issues to the Quality Manager.
• Carry out product segregation and quarantine actions when necessary.
• Ensure testing requirements are met at all stages of the production process and that appropriate documentation is.
• Ensure accurate records of any inspection and test activity are completed and forwarded to the Quality Manager for review against specified targets.
• Develop a thorough knowledge of the Operating Procedures, Work Instructions and Quality Forms relevant to the various Production areas and Goods In.
• Assist the Quality department with Quality System/Product development administration tasks as.
• Provide accurate data relating to inspection levels for analysis by the Quality Manager.
• Demonstrate best production assembly techniques and hygiene practices and be able to lead and train production operatives by example.
• Be able to clearly define pass/fail criteria to Production staff, providing guidance on Quality issues without impacting negatively on the work efficiency of staff.
• Assist the Quality Manager to review the effectiveness of preventive actions taken in response to product quality issues raised.

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.

WHAT WE’RE LOOKING FOR

• Minimum of 5 GCSEs or equivalent, including Math and English and/or several years’ experience within in a medical device manufacturing environment.
• Experience in a regulated manufacturing environment with involvement in Quality-related activities, and an understanding of recognised quality standards and compliance requirements.
• Strong interpersonal and communication skills.
• Able to quickly build effective professional working relationships.
• Meticulous with high levels of attention to detail.
• Strong command of written English.
• Excellent organisational and planning skills to deliver efficient QMS based outputs.
• Proactive and able to work unsupervised.
• Ability to work well in a team.
• Competent in the use of Microsoft office.
• Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
• Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP).
• Experience of using an electronic quality management system (eQMS).
• Experience in good documentation practices (GDP).
• Experience in a medical device / life sciences environment.
• Experience of using problem solving and root cause analysis tools (8D, FMEA etc.).
• Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues.
• Experience in development of training materials and delivery of training presentations.
• Quality auditing certification.
• Methodical with analytical and problem-solving.

ADDITIONAL INFORMATION

• Occasional travel as & when required to other Eakin Healthcare sites.