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Search Results for QA RA Engineer
Job Title. Location Salary Actions

Senior Quality Engineer

SENIOR QUALITY ENGINEER Our Client, One of the largest medical device companies based in Galway is currently recruiting Senior Quality Engineer . The successful candidate will lead and work as part of a team to maintain high quality and performance standards on all Medical products. Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision. The Role • Lead and drive QA initiatives within area of functional responsibility. • Provide quality inpu...

Location: Galway,
Senior Quality Engineer
Galway Not Disclosed

Quality Manager Combination Products

Quality Manager Combination Products Our client, a global pharmaceutical organisation are currently recruiting for a Quality Manager to join their team on a permanent basis. The ideal candidate will have experience working with Combination Products. Responsibilities • Quality lead for Design reviews of Combination Products and Devices in conjunction with Device Development Team, Regulatory Affairs, R&D and Market Research Teams. • Quality lead for risk benefit analysis for combination products/device programs • Manage Quality Combination Produ...

Location: Dublin,
Quality Manager Combination Products
Dublin Not Disclosed
Other Medical Device Jobs
Job Title Location Salary Actions
Quality Engineer Cork €40000 - €45000
Quality Engineer Limerick Not Disclosed
Manufacturing Engineer Galway €40000 - €45000
Validation Engineer contactor Dublin Not Disclosed
Process Engineer, OSD Dublin Not Disclosed
R&D Project Manager Galway Not Disclosed
Director Device Program Lead Dublin Not Disclosed

QA RA Engineer Career Profile

QA / RA Specialist

A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
Main Responsibilities
  • Apply technical solutions to problem solving
  • Apply technical solutions to quality improvement projects
  • Use technical writing skills to clearly describe technical information
  • Analyze customer complaints, identify trends and execute corrective actions
  • Understand standards and their application to medical devices
  • Planning, protocol generation, testing and report generation for medical devices
  • Generation and maintenance of technical files for medical devices
  • Review and update technical files in line with EU medical devices regulatory requirements
  • The use of harmonised standards when compiling a technical file in compliance with the MDD
  • Ensuring that records are filed in accordance with site procedures
  • Supporting R&D

Skills / Experience
  • Engineering / Science qualification
  • 3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
  • Excellent technical writing experience within a medical device environment
  • 2/3 years experience in Risk, Clinical and Biocompatibility an advantage
  • Fluency in English