My client who is an Advanced’ Early Stage Irish MedTech Company is seeking an experienced Senior Quality Engineer to join their business on a permanent basis in Galway.
- Overall responsibility for production GMP standards and compliance.
- Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
- Establishing inspection standards, plans, frequencies and test methods.
- Establishing and maintaining FMEA’s.
- Preparing and updating Operations procedures and associated documentation.
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Develop strong links with customer organisation’s and other project stakeholders.
- Quality review of responsible area validation documentation
- Bachelors Degree in a science/engineering related field
- 3 years+ working at a senior engineer level
- Start-Up experience highly desirable
- Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
Please contact Elaine Dolan for more information
091 706 718