Job Description: Quality Engineer (12-month contract)
We are hiring a Quality Engineer for a 12-month maternity cover contract based in Athlone. This role will focus on maintaining and improving the Quality Management System, ensuring regulatory compliance, and driving continuous improvement initiatives within a medical device environment.
Job Responsibilities
- Lead CAPAs, non-conformances, and root cause investigations
- Support and approve change controls and quality system updates
- Drive process improvements using data and statistical tools (e.g. DOE)
- Ensure compliance with manufacturing, packaging, and labeling standards
- Lead internal and supplier audits and support external inspections (e.g. U.S. Food and Drug Administration, ISO 13485)
- Act as a quality representative in cross-functional teams and site meetings
Job Requirements
- Degree in Engineering, Science, or related field
- 5+ years’ experience in a regulated environment (medical devices preferred)
- Strong knowledge of QMS and regulatory standards (e.g. ISO 13485, FDA)
- Experience with CAPA, audits, and root cause analysis tools
- Good understanding of statistical methods and risk management (e.g. FMEA)
- Strong communication and stakeholder management skills
For more information or to apply, please contact: Brian Stack
Email: brian.stack@collinsmcnicholas.ie
Phone: 090 9703030
