Medical Devices JobsSenior Quality Engineer (Start-Up)

  • GY50939
  • Permanent
  • Galway

Collins McNicholas

My client who is an Advanced’ Early Stage Irish MedTech Company is seeking an experienced Senior Quality Engineer to join their business on a permanent basis in Galway.

Key Duties 

  • Overall responsibility for production GMP standards and compliance.
  • Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA’s.
  • Preparing and updating Operations procedures and associated documentation.
  • Reporting area of responsibility metrics.
  • Supporting customer and surveillance accreditation audits.
  • The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Develop strong links with customer organisation’s and other project stakeholders.
  • Quality review of responsible area validation documentation

Key Requirements

  • Bachelors Degree in a science/engineering related field
  • 3 years+ working at a senior engineer level
  • Start-Up experience highly desirable 
  • Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
  • New product introduction and manufacturing process transfer experience would be a distinct advantage.

Please contact Elaine Dolan for more information 

elaine.dolan@collinsmcnicholas.ie

091 706 718

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