Quality Manager - Medical Devices & Regulatory Excellence

Fuze Health; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Referral bonus programme

Internal opportunities and careersClin

Leave benefits

Flexible annual leave (LetsGetChecked)

Job summary

Fuze Health, based in Ireland, is seeking a Quality Manager to drive quality management systems across locations, ensuring regulatory compliance and continuous improvement. You will act as Management Representative and Person Responsible for Regulatory Compliance, oversee the eQMS, and lead training for Quality teams.

The role emphasizes risk management per EN ISO 14971, internal and external audits, and cross-functional collaboration with Regulatory Affairs, Engineering, and Materials.

Qualifications

• Bachelor’s degree or equivalent in quality management or technical field.
• 5+ years as a Quality Manager in medical devices or IVD.
• Hands-on with risk management and regulatory submissions.
• Experience leading quality teams and audits.
• Experience in controlled rooms / cleanrooms.

Responsibilities

• Serve as Management Representative and PRRC on behalf of the Director of Manufacturing Quality and Regulatory.
• Oversee eQMS platform and change control processes.
• Lead Quality personnel and develop training across locations.
• Maintain EN ISO 14971 risk management program and updates.
• Lead internal audits, participate in third-party audits, and support management reviews.
• Drive CAPA, Kaizen, NCR for quality improvements and issue resolution.
• Maintain KPI reporting across locations and share best practices.
• Execute design and continuous improvement projects within budget and schedule using Lean, Six Sigma, safety and cost reduction.
• Travel nationally and internationally as needed to support sister locations.

Skills

QMS Governance

Regulatory Compliance

Leadership

Cross-functional Collaboration

Quality Improvement

Education

Bachelor’s degree in Quality Management, Engineering, or a technical discipline

Job description

Fuze Health, based in Ireland, is seeking a Quality Manager to drive quality management systems across locations, ensuring regulatory compliance and continuous improvement. You will act as Management Representative and Person Responsible for Regulatory Compliance, oversee the eQMS, and lead training for Quality teams.

The role emphasizes risk management per EN ISO 14971, internal and external audits, and cross-functional collaboration with Regulatory Affairs, Engineering, and Materials.