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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 thomas.gallagher@lifescience.ie