Quality Systems Manager (QMS) – Medical Devices - Athlone
About the Company
Our client is a leading medical device company with a strong global presence, committed to innovation, quality, and patient safety. Operating in a highly regulated environment, they maintain best-in-class quality standards across all operations.
About the Role
This is a senior Quality Systems (QMS) role focused on the ownership, development, and continuous improvement of the Quality Management System (QMS).
You will work cross-functionally to ensure compliance with FDA regulations, ISO 13485, and global medical device standards, while driving continuous improvement and quality excellence across the organisation.
This is an ideal opportunity for an experienced Quality Systems Specialist or QMS Manager looking to take ownership of a critical function in a growing organisation.
Key Responsibilities
- Own and maintain the Quality Management System (QMS) in line with FDA 21 CFR Part 820 and ISO 13485
- Drive continuous improvement initiatives across quality systems and processes
- Monitor and analyse quality metrics including CAPAs, complaints, and audit findings
- Manage and support the internal audit programme, ensuring compliance and follow-up actions
- Act as the primary contact for regulatory and notified body audits and inspections
- Support CAPA processes, including root cause analysis and effectiveness checks
- Contribute to risk management and design control activities
- Prepare and present quality performance data and KPIs to senior stakeholders
- Collaborate cross-functionally to enhance quality systems and regulatory compliance
Requirements
- Bachelor’s Degree in Science, Engineering, or a related discipline (Master’s desirable)
- Minimum 5+ years’ experience in Quality within the medical device industry
- Strong experience in Quality Systems or QMS ownership
- In-depth knowledge of ISO 13485 and FDA 21 CFR Part 820
- Experience supporting audits and regulatory inspections
- Familiarity with ISO 27001 is an advantage
- Strong analytical, organisational, and problem-solving skills
- Excellent communication skills with the ability to engage with senior stakeholders
Why Apply?
- Join a growing medical device organisation with global reach
- Take ownership of a critical QMS function
- Work in a high-impact, cross-functional role
- Strong opportunities for career progression and development
Apply Now
If you are an experienced Quality Systems Manager or QMS Specialist seeking your next opportunity in the medical device sector in Ireland, apply today or contact us for a confidential discussion.
