A Quality Engineer for Operations, is required by CareerWise Recruitment for our Galway based client. The Operations Quality Engineer is a member of the Operations Quality group and is 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 Medical products. This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Medical Quality System. CAPA & Project Management experience desired...Please contact Tom Devaney for more information.
Role of this position
- 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 organisation's and other project stakeholders.
- Quality review of responsible area validation documentation.
- Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
- 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.
- Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485.
- Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
- Level 8 Degree in Quality or Science / Engineering A PREREQUISITE.
- 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.
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)