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

Quality Systems Manager

Role: Quality Systems Manager Location: Newenham Court, Malahide Team: 8 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Competitive salary, 10-15% bonus, pension and full family healthcare Day to day: Manage and maintain the Quality Management System for GDD - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization); Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager 		EU Not Disclosed

Quality Engineer

Title: Quality Engineer Location: The Digital Hub, Rainsford St, Dublin 8. Benefits: Competitive salary, Health insurance and Hybrid working Company: My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'. Having launched i...

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

Senior Quality Control Engineer

Role: Senior Quality Control Engineer Location: Dun Laoghaire, Dublin Benefits: Competitive salary, yearly bonus, pension and healthcare. Company: My client are a Medical Device multinational Driven by a sense of urgency to advance what’s next in diabetes. Role: Senior Quality Control Engineer role is to lead a team of Quality Associates and work directly with the Quality Operations Team Leader on quality engineering activities associated with the day to day operations. - Rep...

Location: Dublin, Dublin South,
Senior Quality Control Engineer 		Dublin Not Disclosed

Senior Supply Quality Engineer

Role: Senior Supply Quality Engineer Location: Parkmore, Galway (4 days a week on site) Benefits: Excellent salary, 10% yearly bonus, pension and healthcare Company: Global leader in medical technology, services and solutions with roots in Ireland since 1981, the company now employs more than 4,000 people across 5 sites in Ireland. Role: They will liaise with our extensive network of suppliers to execute on quality improvements, cost savings, while managing and implementing Supplier and Medtronic driven changes. Part of a larger team within supplier qu...

Location: Galway, Galway City,
Senior Supply Quality Engineer 		Galway Not Disclosed

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
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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