Design Assurance Engineer required by a market leading Medical Device multinational based in Galway.
- Performs technical reviews of design documentation and labeling.
- Coordinates and facilitates completion and update of design risk management documentation.
- Support new test development and appropriate validation.
- Quality approver on all relevant records.
- Plan and conduct software validation on device and supporting software.
- QA lead for product design transfer/validation strategy development and implementation.
- Supports external audits including notified body and FDA audits.
- Promotes the awareness of regulatory and customer requirements.
- BSc. in Engineering, Technology, or Science.
- 2-4 years experience working in a regulated device or pharmaceutical company.
- Knowledge of mechanical ventilation and accessories advantageous.
- Excellent data analysis skills.
- Ability to work within a team environment.
- Excellent understanding of ISO 13485 and FDA QS regulations.
- Understanding of R&D stage gate process.
- Ability to understand and apply relevant medical device standards.
- Some travel may be required.
Please contact Emer Smith to discuss in confidence