Principal Quality Assurance Specialist for Medical Devices

1 month ago


Glostrup, Glostrup Kommune, Denmark Agilent Technologies, Inc. Full time
Quality Assurance in Medical Device Development

As a Principal Quality Assurance Specialist at Agilent Technologies, Inc., you will play a pivotal role in ensuring the development of medical devices meets rigorous quality standards. This position involves working closely with cross-functional teams to identify innovative solutions that balance business needs with regulatory requirements.

The ideal candidate will possess a Master's degree in Biotechnology, Engineering, or a related field, along with 4+ years of experience in In Vitro Diagnostics (IVD), Medical Devices, and/or Pharmaceuticals. Proficiency in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA is essential.

Key responsibilities include conducting design control activities, reviewing and approving design documents, and driving quality initiatives to support process improvements. Additional tasks may include product investigation support, internal and external audit participation, and regulatory submissions.

We offer a dynamic and adaptable work environment, opportunities for professional growth, and a competitive salary range of $90,000 - $140,000 annually, depending on location and experience. Benefits include core global benefits, stock purchase plan, life insurance, pension, healthcare, physiotherapy, and more. We strive for an inclusive workplace where everyone feels valued and empowered to make a difference.



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