Medical Device Quality Assurance Specialist
5 days ago
We are a leading multinational organization in the life science industry, dedicated to delivering high-quality medical devices. Our team is passionate about ensuring compliance with regulatory standards and promoting operational excellence.
Job Description
We are currently recruiting for an exciting opportunity with our medical device organization based in Limerick. This role is ideal for someone looking to join a renowned company that sets the standard in quality assurance.
Duties:
- Support the activities of Operations, Engineering, and Information Management in building product quality into our products.
- Work with various departments to develop and execute validation activities for new equipment or system upgrades.
- Manage complaint investigations and resolutions.
- Design and develop validation documentation for business continuity and process improvement requirements.
- Implement and coordinate change control processes to ensure timely approval of supporting documentation.
- Maintain awareness of environmental and health & safety impacts of work performed.
Education & Experience:
- Familiarity with relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to Class III medical devices for global markets.
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