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

Principal Design Assurance Engineer

Job title: Principal Design Assurance Engineer Location: Parkmore Business Park, Galway. Benefits: Excellent salary, bonus, pension, healthcare, opportunity to grow your career with hugely exciting Medical Device organisation. Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies. The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that wi...

Location: Galway, Galway City,
Principal Design Assurance Engineer 		Galway Not Disclosed

Quality Engineer

Title: Quality Engineer Location: Galway business park, Galway Benefits: Salary, share options, pension, hybrid working and healthcare Company: My client are a growth stage medical device company, dedicated to improving the quality of life for stroke patients. Developing innovative catheter-based technology to extract blood clots from the brain following an Acute Ischemic Stroke, recently received FAD approval. Overview: As a Quality Engineer you will provide support in quality systems, supplier quality and manufacturing act...

Location: Galway, Galway City,
Quality Engineer 		Galway 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