Senior Quality Engineer
Title: Senior Quality Engineer
Location: Galway, Ireland
Multiple Quality Engineering opportunities available with our client based in Galway. An excellent opportunity to join one of the worlds leading Medical Device company.
- Working with the Supervisors and Manufacturing Engineering, promote the achievement of the health and safety goals.
- To deliver on all KPIs that help the business achieve its goal.
- The Operations Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
- 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.
- Establish inspection standards, sampling plans and test methods.
- Prepare and update Operations procedures and associated documentation.
- Support customer audits and surveillance/accreditation audits.
- Conduct 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 Degree in Science / Engineering.
- Experience within a similar role as 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.
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential.
To apply for this role please forward your cv to [email protected]+ APPLY
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