Senior Validation Engineer for Medical Devices
3 days ago
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:
- Support the development and execution of validation activities for new equipment or system upgrades.
- Collaborate with various departments to build product quality into our products.
- Investigate and resolve complaints related to our medical devices.
- Develop and maintain validation documentation to support business continuity and process improvement requirements.
- Ensure timely approval of supporting documentation through effective change control processes.
- 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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