Senior Validation Engineer for Medical Devices

3 days ago


Limerick, Limerick, Ireland Life Science Recruitment Full time
Quality Assurance Role for Medical Devices
We're seeking a highly skilled individual to join our team as a Senior Validation Engineer for Medical Devices. As a key member of our Operations department, you will play a crucial role in ensuring the quality and safety of our medical devices.

About the Role:
This is an excellent opportunity for someone who is passionate about quality assurance and wants to join a leading multinational organization in the life science industry.

Main Responsibilities:
  1. Support the development and execution of validation activities for new equipment or system upgrades.
  2. Collaborate with various departments to build product quality into our products.
  3. Investigate and resolve complaints related to our medical devices.
  4. Develop and maintain validation documentation to support business continuity and process improvement requirements.
  5. Ensure timely approval of supporting documentation through effective change control processes.
  6. Awareness of environmental and health & safety impacts of work performed.

Requirements:
  • Strong knowledge of regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to Class III medical devices for global markets.


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