Quality Specialist in Larne

Terumo BCT is a global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. We have an exciting opportunity for a Quality Specialist to join Terumo BCT - Larne Sites. The successful candidate will provide quality support for the business by assisting management in complying with worldwide regulatory requirements. Investigate customer complaints, review records and provide other services to this end. Act as a contact point in regard to customer complaints.

Essential Duties:

• Receipt, decontamination and investigation of returned BCT disposables.
• Work independently to accomplish established objectives, perform varied quality/regulatory activities such as: investigation and co-ordination of customer product quality complaints, processing of returned goods, and performance of regular quality system audits.
• Progression to Adverse Event Reportable Complaints which may result in Field Action Evaluation decisioning.
• Participate in continuous improvement projects, both process and product-related.
• Work in conjunction with manufacturing, engineering and other functional groups on regulatory compliance issues.
• Develop or participate in the development of solutions to problems of moderate to intermediate complexity.
• Interpret, execute and recommend modifications to operating policies where appropriate.
• Provide accurate and timely turn-around on complaints, returned goods and other activities.
• Maintain related reports that are accurate and concise.
• Independently design and perform routine testing, project experiments, analysis of data and report results.
• Take initiative and demonstrate an inquisitive approach to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Customer centric approach, ability to implement a flexible work schedule.
• Responsible for fulfilling FDA and international regulatory requirements relevant to each project, such as GMP, IDE, PMA, 510(k) and ISO.
• Knowledge and experience of the vigilance reporting of Manufacturer Incident Reports (MIRs) to the authorities as per current UK Medical Device Regulations.

Education:

• Degree in Life Science, Engineering or relevant subject.

Experience:

• Significant experience in a quality-related role within a pharmaceutical/medical device manufacturing environment.

Skills:

• Good PC skills (i.e. MS Office, databases etc).
• Excellent interpersonal and communication skills.
• Tactful and diplomatic whilst remaining assertive and persistent.

Attributes:

• Ability to diagnose problems and recommend solutions.
• Knowledge of manufacturing protocols, statistical tools and methodologies, and continuous improvement techniques.
• Able to work as part of a team.
• Ability to work to strict deadlines.
• Takes ownership of issues/problems and actively seeks to resolve them.

Additional Information:

• It may be a requirement of the role to travel internationally for extended periods.

If you are ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV via our Terumo BCT career’s portal mySource before the closing date of 5pm Monday, 19th January 2026. You must clearly demonstrate on your CV/application how you meet the required criteria as failure to do so may result in you not being shortlisted. Join us in driving progress and supporting patients locally and across the globe every day by contributing to society through healthcare!