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

Senior Post Market Surveillance Specialist

Senior Post Market Surveillance Specialist JOB PURPOSE The successful candidate will act as the primary contact for registering confidential complaints and/or product dissatisfaction. They will receive, answer and document customer complaints, telephone or written, on all products and maintain complaint information in line with regulatory requirements. KEY RESPONSIBILITES • Key responsibilities will include (but are not limited to) the following: • Receive and log product complaints from a variety of sources. • Document and coordinate the in...

Location: Westmeath,
Senior Post Market Surveillance Specialist 		Westmeath Not Disclosed
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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