Our Client a medical device company in Galway are currently recruiting for a Quality Engineer
The Quality Engineer is a member of the Operations Quality group.
The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality / performance standards on all Company products. The focus of the role is to supply high quality medical devices and components to deliver an Extraordinary Customer Experience.
Our Company’s Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release.
- The Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
- The Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company’s Quality Management system and ISO14971.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations.
- Develop strong links with customer organization’s and other project stakeholders.
- Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues using industry-standard problem-solving techniques.
- Overall responsibility for production GMP standards and compliance.
- Establishing inspection standards, sampling plans and test methods.
- Preparing and updating Operations procedures and associated documentation.
- Supporting customer audits and surveillance / accreditation audits.
- Conduct attribute test method validations.
- Support the validation activity for process / equipment changes and conduct the quality review and approval of validation documentation.
The Ideal Candidate
- Level 8 degree in Quality or Science / Engineering.
- Experience within a similar role as a Quality Engineer.
- 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
- 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.
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential
For further information on this Quality Engineer role in Galway please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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