Quality Specialist

Quality Specialist

(25_02)

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.

Essential Duties

• Receipt, decontamination and investigation of returned BCT disposables. 
• Works 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.
• Participates in continuous improvement projects, both process and product-related.
• Works 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. 
• Provides 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.
• Takes initiative and demonstrates inquisitive approaches 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.

Education

• Degree in Life Science, Engineering or relevant subject

Experience

• Minimum two years’ 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

• 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

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, 03 February 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!