Our client, a Medical device company in Galway are currently looking to recruit a Quality Manager Operations for their site.
The Operations Quality Engineer is a member of the Operations Quality group. S/he is, responsible for Operations Quality within their prescribed area of functional responsibility. You will be working as part of a team to maintain high quality / performance standards on all Company Medical Products The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.
- 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.
- Level 8 degree in Quality or Degree in Science / Engineering.
- 3 years'+ experience within a similar role as a Quality Engineer.
- Green belt problem-solving qualification preferred.
- 3+ years' 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.
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