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CTO
Galway
QA Manager
Dublin North
QA Manager
Dublin
National Sales Representative
Republic of Ireland
Commodity Manager
Westmeath
Snr QA Specialist
Dublin South
R&D Engineer
Galway
R&D Engineer
Dublin
Administration Support
Dublin North
API Purchaser
Dublin
Supply Chain Analyst
Dublin North
QA Manager
Dublin West
Consultant
Cork
QC Supervisor
Westmeath
Quality Assurance Manager
Republic of Ireland
Automation Technician
Dublin South
QA Manager Biologics
Dublin West
QC Manager
Dublin
Risk Manager
Dublin
QA Manager
Meath
Biostatistician
Dublin City Centre
Program Manager
Westmeath
Consultant
James Cassidy
Life Science

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

Quality, Compliance and Regulatory Affairs Coordinator

Quality, Compliance and Regulatory Affairs Coordinator Our client, one of the leading medical device distributors across Ireland and U.K are recruiting for QCRA Coordinator who will reporting to the QCRA Manager will the Quality, Compliance and Regulatory Affairs requirements. The successful candidate will manage the ongoing maintenance of our compliance requirements ensuring we meet and exceed our contractual and regulatory obligations, providing best practice in QMS. The Position ·Support the Quality Manager in relation to the maintenance of our ISO Quality Man...

Location: Dublin,
Quality, Compliance and Regulatory Affairs Coordinator
Dublin Not Disclosed

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager
Dublin North Not Disclosed

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 Assurance Systems Manager Remote Working Opportunity Dublin Not Disclosed
Equipment Process Engineer (Lyo - Aseptic Sterile Fill Finish) Sligo Not Disclosed
R&D Engineer Dublin Not Disclosed
R&D Project Manager Galway Not Disclosed
Process Engineer, OSD Dublin Not Disclosed
Administration Support Dublin North Not Disclosed
Engineering Technician Dublin Not Disclosed
Senior R&D Engineer Dublin Not Disclosed
Engineering Technician Dublin Not Disclosed
Technical Writer/ Validation Specialist Dublin Not Disclosed
Technical Writer/ Validation Specialist 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