Quality Engineer

Quality Engineer

(25_34)

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 Engineer to join Terumo BCT- Larne.  Come join us today!

The successful candidate will be responsible for overseeing key electronic Quality Management System (eQMS) processes, analysing data derived from the QMS to drive in-process quality improvements through partnership with the Operations team to identify and implement quality enhancement initiatives.

General Duties

• Manage the end-to-end lifecycle of Quality Unit NC, CAPA, and SCAR processes within the eQMS system, ensuring timely documentation, investigation, root cause analysis and closure.
• Collaborate with cross-functional teams including Production, Quality Control, Engineering, and Regulatory Affairs in management of non-conformances and ensure compliance with Good Manufacturing Practices (GMP).
• Review and evaluate non-conformance reports and CAPA effectiveness to confirm resolution and prevent recurrence.
• Facilitate NC and CAPA meetings, track progress and generate periodic reports for senior management and regulatory audits.
• Ensure compliance with EU GMP, US FDA, ICH, and other relevant regulatory guidelines concerning quality management and documentation.
• Monitor eQMS metrics and KPIs related to NC, CAPA, SCAR and prepare reports for management review.
• Provide training and guidance to site personnel on eQMS functionalities and quality processes.
• Drive root cause analysis methodologies such as 5 Whys, Fishbone diagrams, and FMEA to support effective problem-solving.
• Support Quality Management System (QMS) maintenance and improvements
• Proactively identify and mitigate potential quality issues during in-process manufacturing stages by conducting risk assessments, process audits and root cause analyses.
• Collaborate closely with production, engineering, and quality teams to implement robust process controls and preventive measures that reduce variability and defect rates.
• Utilize statistical process control (SPC), Failure Mode and Effects Analysis (FMEA), and other quality tools to monitor trends and drive continuous improvement.
• Lead initiatives to ensure early detection and resolution of quality concerns before they impact downstream processes or final product quality.
• Lead improvement initiatives based on manufacturing floor observations.
• Develop and implement associate-driven quality improvement plans.
• Work with Engineering, Manufacturing, and Supply Chain to ensure product quality from incoming inspection through final release.
• Support validation, process change control, and risk assessments as needed
• Carry out additional duties as required to support the team and organizational goals.

Education

• Bachelor’s degree in Engineering, Quality, or related field.

Experience

• Minimum 3 years’ experience in a GMP environment
• Experience in NC and CAPA investigation and management
• Proficient in Microsoft Office and eQMS software tools

Skills

• Ability to manage multiple priorities and work collaboratively across departments
• Excellent organizational, communication, and problem-solving skills

Attributes

• Ability to work under pressure and work to strict deadlines
• Good interpersonal skills
• Able to work collaboratively across functions and cultures

Additional Information

• This is an on-site role, based at our Larne facility.

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 5:00 pm on Monday, 08 September 2025.    

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!