Are you experienced within design control of medical devices and interested in making a difference in cancer diagnostics worldwide?

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

At our site in Glostrup we develop and produce reagents for in vitro diagnostic of cancer. To fulfil our mission of delivering trusted answers we are currently preparing for IVDR and continuously expanding our product portfolio, whereby we are recruiting an QA Specialist for our Design Assurance Reagent team of currently 9 dedicated members. The team handles product introduction, design changes and quality plans for all reagents developed and produced in Glostrup. We belong to the department Quality Engineering which gives QA support to both Instrument and Reagent development and sustain activities.

To comply to the IVDR update of all our technical files for our legacy products including their risk files are required. It is for this process you will play a vital role by ensuring compliance with regulations and internal procedures within the areas:

• Tech file updating - Creation of best practise examples, review and approval of new documentation
• Risk management -- Review and approval of product FMEAs, process FMEAs and risk reports.

You will also be responsible for QA support for

• Design transfer -- Review and approval of design transfer activities for new product introductions.
• Change request - Review and approval of design changes related to both development and sustain activities.
  
  

To be successful in the role you must possess extended knowledge of risk management and design transfer, have excellent communication and stakeholder management skills, enjoy working in project teams and take pride in delivering documentation at the right quality level at scheduled time. Furthermore, it is important that you can structure work from several projects, are open minded and thrive in a continuously developing environment.