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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Quality Manager


Reference:TG - QM - Galway Location: Galway
Galway City
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager, QA Specialist, Quality Manager, Quality Systems Lead, Quality Systems Specialist

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


Company:
My client are a Medical Device company im 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:
A Quality Manager you are responsible for a high level of oversight and understanding of the impact of quality processes on business needs



Responsibilities:
  • Act as Management Representative as outlined in ISO 13485:2016 5.5.2.
  • Act as Local Actor Administrator (LAA) for EUDAMED database
  • Reporting to top management on the effectiveness of the quality management system and any need for improvement.
  • Manage and maintain the quality management system in compliance with the Medical Device Directive (MDD), Medical Device Regulation (MDR) EU 2017/745, the FDA Quality Management System Regulation 21 CFR 820 and ISO 13485.
  • Promote awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
  • Identify and manage resources required for effective functioning of QA activities.
  • Management of internal and external audit programs as well as lead for Notified Body and FDA inspection audits.
  • Management of Corrective and Preventive Action process
  • Management of Risk Management activities, ensuring appropriate risk evaluations are documented to support change control activities.


Requirements:
  • Degree in Engineering, Science or health-related discipline.
  • 7+ years’ experience in quality assurance in the medical device industry.
  • Experienced in the support of outsourced manufacturers and suppliers to identify and mitigate supply chain risks related to quality assurance.
  • Excellent 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
  • Skilled in Class 8 cleanroom 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 [email protected]