Quality Systems Engineer – Galway
This is key role within a leading medical device company. You will be responsible for conducting internal audits as well as facilitating external audits.
- Coordinate the internal audit system and audit team to ensure completion of all.
- Conduct Quality Audits as necessary.
- Lead preparation and coordination activities for external audits.
- Co-ordinate the document control function in conjunction with the appropriate resources.
- Identify regulatory compliance issues.
- Coordinate the complaints system.
- Coordinate quality system review and reporting.
- Promotes the awareness of regulatory and customer requirements.
- Supports quality training on site.
- Manage the environmental monitoring process and system for the organisation.
- BSc. in Engineering, Technology, or Science.
- 3-5 years’ experience working in a regulated medical device.
- Excellent planning and coordination skills.
- Ability to communicate quality / regulatory concepts effectively.
- Excellent understanding of EN ISO 13485:2016, MDSAP ad FDA regulations.
- Formal Audit Training
- Proficient in MS office package.
- Some travel may be required with the role.
- Must be authorised to work in Ireland.
Please contact Mary-Ann Keena to learn more
+353 (0) 83 0220666