Quality Assurance Engineer – Galway
Interested in working for a leading medical device manufacturer? You will be responsible validating all design activities within the organisation.
- Performs technical reviews of design documentation and labeling and attends reviews.
- Coordinates completion of design risk management documentation and acts as reviewer for all design activities.
- Support new test development and appropriate validation.
- Quality approver on all relevant records, tests, validations, reports, project file entries etc.
- Implement software validation on device and supporting software based systems.
- QA lead for product design transfer/validation strategy development.
- 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 medical device company
- Experience in software validation advanaegous.
- Excellent planning and coordination skills.
- Knowledge of mechanical ventilation advantageous
Formal training in medical device risk management advantageous.
- Excellent data analysis skills.
- Excellent understanding of ISO 13485 and FDA QS regulations.
- Understanding of R&D stage gate/waterfall process.
- Ability to apply relevant medical device standards.
- Some travel may be required.
- Must be authorised to work in Ireland.
Please contact Mary-Ann Keena to learn more
+353 (0) 83 0220666