Senior Quality Assurance Specialist for In Vitro Diagnostics

2 weeks ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time

Are you a highly skilled professional with experience in quality assurance for medical devices? Do you have a passion for ensuring compliance with regulatory requirements and driving continuous improvement in product development?

We are seeking a Senior Quality Assurance Specialist to join our team at Agilent in Glostrup, Denmark. As a key member of our QA department, you will be responsible for ensuring the quality and safety of our reagents, instruments, and software for in vitro diagnostic of cancer.

The successful candidate will have a strong background in quality systems, including ISO13485, FDA CFR21 Part 820, and MDSAP. They will also possess excellent analytical and communication skills, with the ability to work effectively in a dynamic and adaptable environment.

In this role, you will be responsible for:

  • Providing guidance on design control activities to identify innovative and efficient solutions for various quality topics
  • Conducting reviews and approvals of design control documents, design changes, nonconformances, CAPAs
  • Driving quality initiatives to support continuous improvements of our processes

You will report to the Manager, Development QA and work closely with cross-functional teams, including R&D, RA, Production, and Marketing.

To be successful in this role, you will need to have:

  • A Master's degree in biotechnology, engineering, or a related field
  • At least 4 years of experience in development of In Vitro Diagnostics (IVD), Medical Devices, and/or Pharmaceuticals
  • Proficiency in Quality System Standards and IVD/Medical Devices legislation in EU and USA
  • Business-oriented mindset and a desire to work in a dynamic and adaptable environment

Our company offers a competitive salary range of DKK 950,000 - DKK 1,150,000 per year, depending on qualifications and experience. We also offer a range of benefits, including core global benefits, Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy, and more.



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