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Snr QA Officer
Dublin North
QA Manager Biologics
Dublin West
R&D Engineer
Dublin
R&D Engineer
Galway
Product Specialist (Microbiology)
Republic of Ireland
Biostatistician
Dublin City Centre
Program Manager
Westmeath
Senior CRA
Dublin
QA Manager
Dublin West
QA Manager
Meath
QA Manager
Dublin North
API Purchaser
Dublin
Snr QA Specialist
Dublin South
Buyer
Cork
Head of Quality
Dublin West
Consultant
James Cassidy
Life Science

+353 1 5079250
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Search Results for QA RA Engineer
Job Title. Location Salary Actions

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
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R&D Engineer Dublin Not Disclosed
Biologics Snr PM contractor Dublin South Not Disclosed
Manufacturing Engineer Galway Not Disclosed
Director Device Program Lead Dublin Not Disclosed
QA Manager Biologics Dublin West €70000 - €80000
Quality Systems Engineer. Westmeath Not Disclosed
Programme Manager Cork €60000 - €65000
Snr Mechanical Engineer contract 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