Medical Device Development Lead

3 days ago


Dublin, Dublin City, Ireland Hyper Recruitment Solutions Full time

About the Role:

We are currently looking for a highly skilled Senior QA Engineer for Medical Devices to join our client's team. The successful candidate will be responsible for ensuring the highest standards in device development and compliance.

Key Responsibilities:
  1. Provide technical support and guidance for device development programs through the design and development lifecycle for combination products.
  2. Develop and maintain Design History Files for development programs, including associated activity plans and timelines.
  3. Collaborate with affiliate sites, collaborators, and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
  4. Contribute to Risk Management activities for development programs through the implementation of ISO 14971:2019.

Qualifications:

  1. Relevant degree in engineering or science/life science.
  2. Significant industry experience in medical device or pharmaceutical (with devices).
  3. A strong understanding of device development and manufacturing operations activities for device or drug/device systems in a GMP environment.


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