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Details

Senior Quality Engineer


Reference:TG - SQE - Galway Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Engineer, QA RA Engineer, QA Specialist, QE Manufacturing Engineer, Quality Engineer, Quality Specialist, Quality Systems Lead, Quality Systems Specialist

Title: Senior Quality Engineer
Location: Galway business park, Galway
Benefits: Salary, share options, pension, hybrid working and healthcare


Company:
My client are a Medical Device company in a growth stage. 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.



Culture:

  • An inclusive work environment, where all the employees are valued, supported, and encouraged.
  • All employees have a seat at the table and have influence.
  • A collaborative teamwork environment where learning is constant, and performance is rewarded.
  • The opportunity to be at the forefront of a technology that can positively impact the treatment of one of the world's most devastating diseases


Overview:
As a Senior Quality Engineer you will provide support in quality systems, supplier quality and manufacturing activities with a focus on continuous improvement of products and processes.



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 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, implementation of corrective actions, and closure.


Requirements:
  • Degree in Engineering or Science discipline.
  • 5+ years’ quality or manufacturing experience in the medical device industry
  • Thorough knowledge of Good Manufacturing Practice as described in US and European regulations for medical device manufacture.
  • Excellent knowledge of the application of ISO 14971; Risk Management, throughout the QMS.
  • Demonstrated ability to make challenging decisions to support continued supply of products, while also maintaining compliance.


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 thomas.gallagher@lifescience.ie