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QA Engineer

Posted On:  29-Sep-2020
Job Category:  Operations, Quality & Engineering
Department Info

The cardiovascular production plant of Terumo Europe in Knowsley (near Liverpool) produces medical equipment that help saves people’s lives daily.  Our UK plant was founded in 1996, and we employ 113 associates that contribute every day to society through healthcare.

Job Summary

Designing and implementing tests, debugging and defining corrective actions. Reviewing system requirements and track quality assurance metrics. Assisting in QA documentation maintenance, audits, management reviews and product complaints.

Job Responsibilities

1.    Create detailed, comprehensive and well-structured quality test plans and test cases in the laboratory or cleanroom.
-Develop and apply quality testing processes for new and existing products to meet client needs.
        -Determine and apply incoming inspection testing.
        -Determine and apply complaint and Non confirmative testing.
        -Stay up-to-date with new testing tools and test strategies
-Establish, follow up and implement preventive/corrective actions for 
 Non-conforming products or processes.
2.    Review requirements and specifications on quality documents to provide timely and meaningful feedback.
    -Write and implementing a testing procedure and protocol.

3.    Ensuring. monitoring and implementing quality control within the SAP system.
        - Ensuring correct recording of stock and lot number
        -Ensuring correct stock allocation, movement and control
        -Blocking stock when required 

4.    Develop and maintain the procedures and standards related to the quality assurance of the materials, components and products in pilgrim. 
        -  Ensure that proper control systems are applied on materials, components and 
            products to provide a safe and defect-free product.
-    Information gathering of KPI’s  and complaints for measuring, monitoring
   and reporting to the management review
-    Quality control of Labels and Instructions for use
-    Liaison with Regulatory Authorities on all aspects of registration.

5.    Helping with the handling of product complaints and the evaluation of the countermeasures developed on preventing reoccurrence. 
-  Help with the handling of the products recall from the market, in conjunction      
    with the President, Quality Systems Manager and Regulatory Affairs    
-  Helping with quality response to product complaints 

6.    Identify, analysing and stop non-conforming products, CAPA or materials
        -Investigate the causes of quality non-conformances, CAPA and train 
          personnel to implement solutions.
                 - Evaluate the subcontractors and materials vendors
        - Creating and maintaining a quality suppliers rating system
        - Quality assurance approval of validation project

7. Creating, controlling and developing continuous quality improvements within UK plant
        -  Coordinating and dealing with external audits and customers visits 
        -  Control the products and their manufacture in compliance with the product 
        -  Project Management for quality improvement 

Profile Description
  • Relevant University degree
  • Min 1 years of experience in quality and regulatory affairs
  • Working exerience and knowledge of ISO 13485.
  • Wokring experience and knowledge of quality systems and testing.

We offer a full- time employment contract, a competitive salary package with additional benefits.
Working in an organisation that values care, quality, creativity, integrity and respect.  All Terumo associates contribute every day to the society through healthcare.
Access to our L&D library able to drive your own learning journey by developing your soft skills. 

Contact Person

Nathalie Hoyle 

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

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