Job Description
Quality Assurance (QA) Specialist to IVDR technical files
Make a global impact in cancer diagnostics – Join us at Agilent
Are you passionate about making a difference in cancer diagnostics? Do you have experience with design control of medical devices? If so, we’d love to hear from you.
At Agilent, we inspire and support discoveries that improve quality of life. We equip life science, diagnostic, and applied market laboratories around the world with instruments, services, consumables, applications, and deep scientific expertise. Our solutions empower our customers to find answers that help them do what they do best—make the world a better place. Learn more at www.agilent.com.
At our Glostrup site, we specialize in developing and manufacturing reagents for in vitro cancer diagnostics. In our mission to deliver trusted answers, we are currently strengthening our readiness for the EU In Vitro Diagnostic Regulation (IVDR). As part of this growth, we are looking to add a QA Specialist to our dedicated IVDR QA team, currently composed of five skilled professionals.
The IVDR QA team is responsible for managing design documentation for products currently on the market. We provide quality support for reagent devices and play a key role within the Quality Assurance department, upholding the highest standards in compliance and product quality.
In this role, you will play a key part in supporting the IVDR transition for legacy products, ensuring full compliance with both regulatory requirements and internal quality procedures.
Key responsibilities
- Review and approve newly created or updated documentation
- Develop, maintain, and share best practice examples
- Drive continuous improvement in design documentation processes
Primary areas of focus
- Device description
- Product requirements
- Design outputs specifications
- Manufacturing information
- Design usability
- Risk management
- Product performance evaluation
- Product stability
- Labelling
- Post-market surveillance
- Regulatory submission files
- Quality and change plans
- Additional design history file (DHF) documentation
Qualifications
Qualifications:
- Master’s degree in Biochemistry, Engineering, or related field of study.
- Preferably 2+ years of experience in design control within medical devices or in vitro diagnostics.
- Preferably 2+ years of experience in Quality Assurance.
- Perhaps knowledge of the compliance standards ISO 13485, ISO 14971, and IVDR.
- Full fluency in English. Fluency in Danish is not required but preferable.
- On a personal level, you are process and detail oriented, proactive and have great interpersonal skills.
To be successful in the role you must have good 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.
Join Us in Making a Difference
At Agilent, your contributions will directly support the advancement of cancer diagnostics worldwide. You’ll work in a collaborative environment with a dedicated team that values quality, innovation, and continuous improvement. This is a unique opportunity to be part of a meaningful mission—delivering trusted answers that improve lives.
If you're ready to apply your expertise in design control and quality assurance to help shape the future of diagnostic solutions, we look forward to hearing from you.
Apply today and help us make an impact that matters.
Additional Details
This job has a full time weekly schedule. Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
