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

• 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.

• 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.