Job Description

As a healthcare company committed to protecting the health and safety for our employees, contractors, customers and communities, employees in this role are required to be fully vaccinated against COVID-19, unless an accommodation has been granted for a medical reason or sincerely held religious belief.

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 .

The LSAG Quality organization is looking for a Quality Engineer to manage all aspects of the Quality Management System (QMS) for our Software & Informatics Division (SID) to make sure our processes are efficient, effective and meet all applicable regulations. This includes guidance, training, consulting, and hands-on support for SID and the continuous improvement of our process in close cooperation with other divisions of LSAG.

Key objectives will be the following:
- Develop and improve key QMS processes. Monitor and provide consulting of functional QMS processes.
- Manage Document Control and Supply management in SID.
- Manage QMS issue resolution (CAPA)

- Host / manage local audits (internal, Registrar, customer) and SME / owner for key QMS topics
- Facilitate customer questionnaires (in cooperation with WWCQ team and business teams)

- Facilitate SID Computer system validation (CSV) activities.

- Provide consultant for Software Regulatory Compliance (GMAP5, CSV, Data integrity, Cybersecurity)