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Project Engineer
Limerick
Senior R&D Clinical Engineer
Republic of Ireland
Head of R&D
Galway
Regulatory Affairs Specialist
Republic of Ireland
Quality Engineer
Limerick
Project Engineer
Tipperary
Engineering Technician
Dublin South
R&D Engineer
Galway
R&D Engineer
Dublin
Quality Specialist
Tipperary
Project Engineer
Limerick
R&D Manager
Galway
GCP Inspector
Dublin
Process Engineer
Limerick
Production Team Lead
Dublin South
Medical Device Director
Republic of Ireland
R&D Manager
Galway
Controls Engineer
Dublin South
R&D Engineer
Limerick City
Project Engineer
Limerick
Project Manager
Limerick
R&D Manager
Galway
Project Engineer
Limerick
VP Clinical Development
Republic of Ireland
CQV Lead
Tipperary
R&D Engineer
Galway
Senior CSV Specialist- Hybrid
Republic of Ireland
C&Q Engineer
Dublin
Senior R&D Engineer
Limerick City
Project Manager
Limerick
Quality Engineer
Limerick
Project Engineer
Republic of Ireland
CAD Technician
Republic of Ireland
CSV Engineer
Limerick
QC Leader
Cork
Consultant
James Cassidy
Life Science

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

Quality Engineer

Role: Quality Engineer Location: Can be on site in Galway or Dublin 1 Benefits: Competitive salary, yearly bonus / Share options Company: My client are an early stage Medical Device company working developing an innovative medical device technology to treat Benign Prostatic Hyperplasia (BPH). BPH is an enlargement of the prostate gland causing significant discomfort and affects more than 50 percent of men over 50 years of age. Currently have 25+ employees and a management team with a proven track record of bringing innovative medical technology ...

Location: Dublin, Dublin City Centre,
Quality Engineer
Dublin Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...

Location: Dublin,
Senior Regulatory Affairs 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