Quality System Engineer – Galway
An excellent opportunity to join a medical device team in maintaining and collaborating with the entire team to ensure compliance is being achieved.
- Coordinate the internal audit system and audit team.
- Conduct quality audits as necessary.
- Coordinate external audits and ensure audits are conducted efficiently.
- Coordinate the document control function.
- Identify any adverse trends or regulatory compliance issues.
- Coordinate the complaints system to ensure that all complaints are completed.
- Coordinate quality system review activities and reporting.
- Promote the awareness of regulatory and customer requirements.
- Supports quality training on site.
- Methodical review approach and be capable of initiating and leading change and continuous improvement.
- Manage the environmental monitoring process and system for the manufacturing area.
- BSc. Degree in Engineering, Technology, or Science
- 3-5 years’ experience working in a regulated environment – medical device or pharmaceuticals
- Understanding of EN ISO 13485:2016, MDSAP ad FDA regulations
- Formal Audit Training
- Excellent planning and coordination skills
- Excellent verbal and written communication skills
- Excellent attention to detail skills
- Ability to work within a team environment to achieve agreed company goals
- Ability to communicate quality / regulatory concepts
- Some travel may be required with the role
- Must be authorised to work in Ireland
Please contact Emer Moore to discuss in confidence