Design Assurance Engineer with excellent understanding of ISO 13485 and FDA QS regulations required for Galway role. Due to continued expansion into global markets, my client – a growing Irish medical devices company – is seeking to recruit a Design Assurance Engineer to take responsibility for Medical Product (CE Mark and FDA 510k) Design Assurance, Product and Process Validation System and Risk Management Activities.


  • Degree in Engineering, Technology or Science.
  • At least 3-5 years’ experience working in a regulated medical device or pharmaceutical company
  • Excellent understanding of ISO 13485 and FDA QS regulations
  • Understanding of Quality Systems
  • Understanding of Design Control Process
  • Training in product risk management, problem solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous
  • Ability to communicate quality / regulatory concepts effectively
  • Excellent planning and coordination skills
  • Excellent verbal and written communication skills
  • Excellent attention to detail skills
  • Ability to work within a team environment to achieve agreed company goals
  • Proficiency in use of desktop software applications such as MS office, Word, Excel, PowerPoint
  • Some travel may be required with the role


  • Performs Design Assurance activities including technical reviews of design documentation and labeling
  • Attends at design reviews, coordinates and facilitates completion and update of
    design risk management documentation and acts as independent reviewer for all design activities including design changes
  • Support new test development and appropriate test method validation (TMV)
  • Technical reviews of Process Validation deliverables including IQ, OQ and PQ as well as input to computer system validation (CSV) where required
  • Implement updates to applicable quality system requirements
  • QA lead for Product design transfer/validation strategy development and implementation
  • Supports external audits including notified body and FDA audits
  • Promotes the awareness of regulatory and customer requirements throughout the
  • Methodical review approach and be capable of initiating and leading change and continuous improvement 

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