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Quality Engineer

  • Location: Galway, County Galway, Connaught, Ireland
  • Job Type:Permanent

Job 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 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:

Qualifications

  • 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.

Key Requirements

  • 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.

christopher.otoole@collinsmcnicholas.ie

091 706713