Medical Devices Quality Engineer with 3+ years experience in medical devices / pharma required by growing multinational in Galway city. You will be responsible for the continuous improvement of the organisation’s Quality Management System and get the opportunity to work on exciting new projects.

Responsibilities:

  • Perform an active role in further development and continuous improvement of the Quality Management system and 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

Requirements:

  • Level 8 B.Sc. Degree in Quality / Science / Engineering
  • 3+ years experience as a Quality Engineer
  • 3+ years experience in a medical device or pharmaceutical manufacturing
  • Green belt problem-solving qualification preferred
  • Strong knowledge of FDA/ISO/MDD Quality systems for Medical device companies
  • New product introduction and manufacturing process transfer advantageous
  • Quality experience in component and device manufacturing desirable

 

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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