****Must have a background in medical device environment****
Overview:
The Quality Manager is responsible for the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure full compliance with applicable U.S. and international regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 27001, and other applicable regulatory requirements.
This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices. This is a permanent opportunity offering hybrid working once probation is passed.
Responsibilities:
- Own and lead the Quality Management System for the division, ensuring ongoing compliance with FDA, ISO, and other global regulatory requirements.
- Ensure QMS effectiveness through performance monitoring, management review, and continuous improvement initiatives.
- Monitor and trend quality system metrics (CAPAs, complaints, audit findings, etc.) and prepare reports for management reviews.
- Support Corrective and Preventive Actions (CAPA) by conducting root cause investigations, effectiveness checks, and documentation.
- Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPI’s and Quality Management Review.
- Management of the Internal Audit program including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
- Lead regulatory and notified body inspections and act as primary quality contact.
- Ensure timely and effective remediation of audit and inspection findings.
- Prepare and present Quality metrics and performance trends to senior management.
- Lead Quality Management Review meetings and drive accountability for actions.
- Building authentic relationships, ensuring cross-functional Quality Systems meetings are held so that Quality Systems can collaborate with all stakeholders of the QMS to drive improvements
Essential Criteria:
- Bachelor’s Degree in a Science, Engineering, or related discipline (Master’s degree desirable).
- Minimum 5+ years’ experience in the Medical Device industry within Quality Assurance/Quality Systems.
- Prior experience in a Quality Manager role – leading activities.
- Experience with medical device software and software lifecycle processes is advantageous.
- Extensive knowledge of ISO 13485 and FDA 21 CFR Part 820 required; familiarity with ISO 27001 required.
- Demonstrated experience leading audits and regulatory inspections with the ability to present findings to management.
- Flexibility to travel to the US and other locations as required to support business activities and Quality Audits.
If this Quality Manager job in Athlone is of interest to you apply now or contact David Smith at Collins McNicholas Recruitment to learn more.
