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 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.
What your background should look like:
Level 8 degree in Quality or Degree in Science / Engineering.
Experience within a similar role as Quality Engineer.
3+ years industry experience in a medical device manufacturing 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.
For more information on the role please contact Christopher O Toole.