Quality Engineer – Medical Devices: Compliance & Risk

Fuze Health Inc.; Dublin; Hybrid; EUR 60,000 - 68,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Referral bonus programme

Career progression opportunities

Parental leave

Job summary

Fuze Health in Dublin is seeking a detail-oriented Quality Engineer to join our manufacturing facility. You will ensure products and processes comply with ISO13485, 21CFR Part820, MDR, IVDR, and ISO14971, supporting change controls, validations, audits, and risk management throughout the product life cycle.

This is a 12‑month fixed-term contract onsite at Dublin11. The ideal candidate has 2–5 years in medical device quality, a Bachelor’s degree in Biomedical Engineering or Quality Management,

Qualifications

• Bachelor’s degree in Biomedical Engineering or Quality Management; master’s degree advantageous.
• 2–5 years of relevant experience in medical device quality.
• Experience supporting new product introductions and risk management files.
• Familiarity with ISO13485, MDR/IVDR, 21CFR Part820, ISO14971; audits experience.

Responsibilities

• Evaluate products and processes for regulatory compliance and quality.
• Support change controls and validation deliverables for equipment and processes.
• Assist in internal/external audits and CAPA investigations.
• Lead risk management activities and maintain risk documentation.
• Collaborate with cross-functional teams to implement changes and drive improvements.
• Handle customer complaints and determine disposition of non-conforming product.

Skills

Quality management

Regulatory compliance

Risk management

Audits

CAPA

Process improvement

Root cause analysis

Statistical methods

Minitab

SAP S/4HANA QM

Education

Bachelor’s degree in Biomedical Engineering

Bachelor’s degree in Quality Management

Master’s degree advantageous

Tools

SAP S/4HANA QM module

Minitab

Job description

Fuze Health in Dublin is seeking a detail-oriented Quality Engineer to join our manufacturing facility. You will ensure products and processes comply with ISO13485, 21CFR Part820, MDR, IVDR, and ISO14971, supporting change controls, validations, audits, and risk management throughout the product life cycle.

This is a 12‑month fixed-term contract onsite at Dublin11. The ideal candidate has 2–5 years in medical device quality, a Bachelor’s degree in Biomedical Engineering or Quality Management,