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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Quality Engineer


Reference:TG - Galway - QE Location: Galway
Galway City
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Engineer, QA RA Engineer, QA Specialist, QE Manufacturing Engineer, Quality Engineer, Quality Systems 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 activities with a focus on continuous improvement of products and processes. They will support the execution of initiatives and projects to enhance quality performance within the business,



Responsibilities:

  • Support the maintenance of a quality management system that complies with the Medical Device Regulation (MDR) EU 2017/745, the FDA Quality Management System Regulation 21 CFR 820 and ISO 13485.
  • Lead quality activities related to outsourced manufacturers and suppliers to ensure compliance is maintained for Perfuze products.
  • Lead risk management activities including hazard/failure mode effects analysis.
  • Drive risk-based problem solving to assure product quality and patient safety through both design activities and manufacturing processes.
  • Work closely with cross functional engineering colleagues to lead product transfer quality deliverables.
  • Lead process verification and validation activities in accordance with quality system policies and practices.
  • Own and manage internal and supplier driven non-conformances (NCs) and CAPAs, ensuring timely containment actions, corrections, root cause investigation




Requirements:
- Degree in Engineering or Science discipline.
- 2+ years’ quality or manufacturing experience in the medical device industry



Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]