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

Senior Sterilisation Quality Engineer

Senior Sterilisation Quality Engineer Our client, a medical device organisation are currently recruiting for a Senior Sterilisation Quality Engineer to join their team on a permanent basis. The Senior Sterilisation Quality Engineer will support sterility assurance activities for the International region in compliance with ISO13485, 21CFR820, European Medical Device Regulation, Japanese PAL and related sterility assurance ISO standards. Responsibilities • Ensure the Sterility Assurance Quality system documentation meet the requirements of 21 CFR Part 820, ISO 13485%2...

Location: Westmeath,
Senior Sterilisation Quality Engineer
Westmeath 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