Quality Engineer - Medical Devices (Onsite Dublin, 12-Month)

LetsGetChecked; United States; On-site; USD 70,000 - 79,000; Full time

Benefits offered by this job

Health insurance

Employee Assistance Programme

Pension

Annual compensation reviews

Referral bonus programme

Internal opportunities and careersClin

Leave policy (maternity/paternity/Par.

Job summary

Fuze Health’s Dublin facility seeks a detail-oriented Quality Engineer to ensure medical device compliance with ISO 13485, 21 CFR Part 820, MDR, IVDR, and ISO 14971. You will support change controls, validations, audits, risk management, and cross‑functional teams to maintain product quality and patient safety.

This 12-month fixed-term, onsite role offers competitive compensation and diverse benefits within a collaborative environment.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Quality Management, or related field.
• 2–5 years in quality within medical devices.
• Experience with ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971, IEC 62366, GAMP5.
• Audits experience (internal/external) a plus; post‑market surveillance knowledge preferred.
• Statistical methods; Lean/Six Sigma; Minitab experience advantageous.
• Strong communication, technical writing, and cross‑functional collaboration.

Responsibilities

• Evaluate current products/processes for regulatory compliance.
• Review/change controls and assist through the change process.
• Approve validation deliverables for equipment and processes.
• Support internal/external audits and resolve findings.
• Lead risk management, maintain docs, assess mitigations.
• Collaborate with cross‑functional teams on changes and automation.
• Handle customer complaints and implement corrective actions.
• Investigate CAPAs and non‑conformances; draft required records.
• Stay updated on regulatory changes and best practices.

Skills

Regulatory compliance

ISO 13485

Six Sigma

Lean

Minitab

SAP QM

Root cause analysis

Technical writing

Cross-functional

Quality culture

Education

Bachelor’s in Biomedical Engineering/Quality Management

Master’s degree advantageous

Tools

SAP S/4HANA QM

GAMP5

Job description

Fuze Health’s Dublin facility seeks a detail-oriented Quality Engineer to ensure medical device compliance with ISO 13485, 21 CFR Part 820, MDR, IVDR, and ISO 14971. You will support change controls, validations, audits, risk management, and cross‑functional teams to maintain product quality and patient safety.

This 12-month fixed-term, onsite role offers competitive compensation and diverse benefits within a collaborative environment.