Quality Manager
On-siteCarrick-on-Shannon, Connacht, Ireland
Job Summary
Lead quality systems development and management while serving as the Management Representative to regulatory bodies and notified bodies. Manage client audits, respond to audit concerns, and act as the primary contact for customer quality issues. Ensure field complaints are addressed per regulatory requirements and integrate quality into strategic planning and new product development. Directly oversee management controls, risk management, inspections, yield improvement, and statistical process control analyses. Monitor site quality performance indicators against global metrics and support lean, continuous improvement, and safety initiatives. Develop team members through performance management and rewards while fostering a high-performance culture.
Required Qualifications
- Degree / Masters Qualified
- preferably in Quality Systems, Regulatory Affairs, Biomedical Engineering or similar
- Minimum of 10 years previous experience involved in Quality Systems compliance within the Medical Devices sector
- Minimum 3 years management experience
- Extensive knowledge and understanding of the ISO 13485, FDA QMSR and GMP regulations
- Knowledge and understanding of ISO 14001, ISO 45001 and ISO 50001
Desired Qualifications
- Lead Auditor qualified preferred
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