We are seeking an experienced QA specialist to support design control and change request from our Reagent Partnership division of Agilent technologies.

Agilent aim to inspire and support discoveries that advance the quality of life. The Reagent Partnership division contributes by developing polyclonal, monoclonal and conjugated antibodies in bulk; either off-the-shelf or customized. In addition, Reagent Partnerships has a comprehensive portfolio of assays for turbidimetry/nephelometry and flow cytometry and we have a significant track record of developing assays for a variety of platforms for some of the largest global IVD companies.

To fulfil Agilents mission of delivering trusted answers Reagent partnership are currently preparing for IVDR along with expansion of their product portfolio, whereby we in support of this are recruiting an advanced 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, which covers the two divisions; Pathology and Reagents Partnership.

You will play a vital role in ensuring compliance with regulations and internal procedures for the products developed by Reagent partnership where your daily activities will be to provide guidance as well as review and approval of documentation within the areas:

• Risk management
• Product requirements
• Output specifications -- review and approval
• Design verification
• Design validation

You will also be responsible for QA support for

• Change request - Review and approval of design changes related to both development and sustain activities.
• IVDR readiness -- Guidance, review and approval of techfile for resubmission of legacy products

To be successful in the role you must possess extended knowledge of risk management and design control, 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.