Process Quality Engineer

Location: Larne, Northern Ireland

Duties will include:

• Work with internal and external stakeholders to resolve quality issues that arise as quickly and efficiently as possible to prevent compromising quality and safety standards.
• Lead Quality focused and continuous improvement projects, working closely with Production, Maintenance and other departments as necessary.
• Manage and coordinate non-conformance investigations and root cause analysis using industry standard techniques. Identify and implement effective corrective actions.
• Report on and communicate Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.
• Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
• Ensure compliance and assist with adherence to the Quality Management System, ISO 13485, cGMP
• Participate in the development and refinement of Process FMEA’s (Failure Mode and Effects Analysis)

Applicants must possess:

• Bachelor’s degree in Science or Engineering related discipline or equivalent of education and experience enough to successfully perform the essential functions of the job may be considered.
• Experience in Root Cause Analysis, critical thinking, investigative techniques.
• Experience gained within a manufacturing environment.
• Strong communication and writing skills.
• Independently determine approach and assigned tasks.
• Good time management and planning skills.
• Ability to work under pressure and to strict deadlines – (this role may necessitate working additional hours and/or shifts as and when required.

In addition, the following would be a distinct advantage:

• Experience gained within a medical device or pharmaceutical manufacturing environment
• Lean 6 Sigma Qualification
• Knowledge of cGMP and EN ISO 13485:2016

If you would like to apply for this role, submit an up-to-date copy of your CV by  5.00 pm on Thursday 21^st January 2021.

Terumo BCT Ltd is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.