NEW ROLE - Quality Engineer Operations - Galway
Looking for your next step?
Permanent Quality Engineer urgently required to support Operations in a busy Medical Devices manufacturing environment.
Essential must have at least 3 years in an Engineering role in Manufacturing
Awesome opportunity to get involved with this expanding multinational in the West.
Responsibilities include, but are not limited to, the following:
- 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.
- Level 8 degree in Quality / Science / Engineering.
- Experience within a similar role as Quality Engineer.
- 3+ years' industry experience in a medical device-manufacturing or pharmaceutical environment.
- Green belt problem-solving qualification preferred.
Immediate response on cvs.