Senior Quality Engineer

Title: Senior Quality Engineer

Location: Galway, Ireland

Summary:

Multiple Quality Engineering opportunities available with our client based in Galway. An excellent opportunity to join one of the worlds leading Medical Device company.

Responsibilities:

• 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.

Requirements

• 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]