Opslag hos Agilent Technologies

Agilent Technologies


Secondary Locations
Job Type
Option to Work Remote
Diagnostics and Genomics Group
Day Job
Job Function
Travel Required
Job Description
Are you experienced within risk management for 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 fullfill our mission of delivering trusted answers we are currently preparing for IVDR and continuously expanding our product portfolio, whereby we are recruiting a new 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 updating of all design history 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:

- Risk management / FMEA

- Design control/ Design history file documentation

- Stability studies / Real time studies

Additionally, you will be responsible for reviewing and approving change request related to both development and sustain activities.

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 high quality documentation 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.

- Master's Degree / PhD in Biotechnology, Biochemistry, Engineering or related field of study.

- At least 5 years' experience in design control/risk management around medical devices / IVD

- Experience in Quality Assurance

- Good knowledge of compliance standard ISO13485 and ISO14971

- Full fluency in English. Note that fluency in Danish is not required but preferable

- On a personal level, you are process and details oriented, proactive and you have great interpersonal skills

Please apply directly online. For more information about the role, please contact Cesar Lecomte: cesar.lecomte@non.agilent.com

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Agilent Technologies - hurtigt overblik

Produktionsvej 42
2600 Glostrup
Logo: Agilent Technologies
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