Quality Specialist

TERUMO BCT, INC; Mid and East Antrim District; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading healthcare technology company is seeking a Quality Specialist in Northern Ireland. You'll be providing critical quality support by ensuring compliance with regulatory requirements, investigating customer complaints, and conducting various quality audits. Candidates should have a degree in Life Science or Engineering, and significant experience in quality roles within the pharmaceutical/medical device sector. The position may require international travel. Join us to make a significant impact in the healthcare sector.

Qualifications

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

Responsibilities

• Provide quality support by assisting management in complying with regulatory requirements.
• Investigate customer complaints and review records to provide comprehensive solutions.
• Perform varied quality/regulatory activities such as investigations and quality audits.
• Participate in continuous improvement projects related to processes and products.
• Work collaboratively with various departments on regulatory compliance issues.

Skills

Excellent interpersonal and communication skills

Tactful and diplomatic whilst remaining assertive and persistent

Education

Degree in Life Science, Engineering or relevant subject

Job description

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Quality Specialist

Date: Jan 5, 2026

Quality Specialist

(25_48)

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. Come join us today!

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.

• Receipt, decontamination and investigation of returned BCT disposables.
• Work independently to accomplish established objectives, performs 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. Develops or participates in the development of solutions to problems of moderate to intermediate complexity. Interprets, executes and recommends modifications to operating policies where appropriate.
• Provide accurate and timely turn‑around on complaints, returned goods and other activities. Maintains related reports that are accurate and concise.
• Independently designs and performs routine testing, project experiments, analysis of data and reports results.
• Take initiative and demonstrate an inquisitive approach to solve moderately complex problems, identifying problem, 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

• 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
• Knowledge of manufacturing protocols, statistical tools and methodologies, and continuous improvement techniques

Additional Information

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

If you're 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!

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