Design Assurance Quality Engineer

Job description

Provides guidance and supports all activities pertaining to the design, development and qualification of new products. Coordinates and prepares product submissions to obtain global approvals for commercial distribution.


  • Interfaces with R&D, Clinical, Marketing, Process Development, Regulatory and Manufacturing to provide technical and quality systems input to new product designs
  • Implements and maintains Design Assurance policies and procedures
  • Provides training on the policies and procedures required to support Design Control
  • Provides the Quality review at defined design review phases to ensure compliance with all required regulatory requirements
  • Generates product risk analysis documentation (design FMEAs) and ensures risk continuity through to process FMEAs
  • Generates associated design plans, protocols and reports for new product development projects as well as design / process changes
  • Compiles the required regulatory data to support new product submissions and notice of change for the global marketplace
  • Provides Design Assurance continuity across development / transfer projects in line with policies and procedures
  • Generates device labeling and advertising materials for compliance with applicable regulations


  • Primary degree or equivalent work experience, preferably in a scientific or technical discipline
  • 3 + years Quality Engineering / Design Assurance experience in the medial device or pharmaceutical industry
  • Thorough knowledge of product development process and design control requirements (product risk analysis, design FMEAs, process FMEAs, design validation, test method development / qualification and statistical techniques)
  • Thorough understanding of FDA, European, Japanese and other international regulatory requirements
  • Ability to coordinate multiple projects
  • Excellent written and oral communication
  • Strong organizational, interpersonal and influencing skills


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent