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

Let'sGetChecked; Ireland; Vor Ort; EUR 60.000 - 68.000; Vollzeit

Benefits dieser Stelle

Health insurance

Pension

Annual compensation reviews

Referral programme

Onsite clinics

Zusammenfassung

Fuze Health, in partnership with LetsGetChecked, seeks a Quality Engineer to join our Dublin-based manufacturing facility and ensure compliance with ISO13485, 21CFR Part820, MDR, IVDR and related standards. This 12-month fixed-term contract involves change controls, validations, audits, and risk management within a fast-paced medical device environment.

Key responsibilities include supporting audits, leading risk management activities, reviewing validation deliverables, and driving continuous

Qualifikationen

• Bachelor's degree in Biomedical Engineering, Quality Management or related disciplines.
• 2–5 years of quality dept experience in medical devices.
• Working knowledge of ISO13485, 21CFR Part820, MDR2017/745, IVDR2017/746, ISO14971.

Aufgaben

• Evaluate products and processes for compliance with applicable regulations and standards.
• Review and support change controls and design changes to maintain compliance.
• Review and approve validation deliverables for equipment and processes.
• Participate in internal and external audits and assist in audit findings resolution.
• Lead risk management activities and maintain risk documentation.
• Collaborate with cross-functional teams to implement changes and automated systems.
• Handle customer complaints and ensure corrective actions are followed up.
• Assist in CAPA investigations and non-conformances, drafting necessary records.
• Stay updated on regulatory changes and advise on quality improvements.

Kenntnisse

Quality Assurance

Regulatory compliance

Audit support

Risk management

Cross-functional collaboration

Documentation

Ausbildung

Bachelor's in Biomedical Engineering/Quality Management

Tools

SAPS/4HANA QM

Jobbeschreibung

Fuze Health, in partnership with LetsGetChecked, seeks a Quality Engineer to join our Dublin-based manufacturing facility and ensure compliance with ISO13485, 21CFR Part820, MDR, IVDR and related standards. This 12-month fixed-term contract involves change controls, validations, audits, and risk management within a fast-paced medical device environment.

Key responsibilities include supporting audits, leading risk management activities, reviewing validation deliverables, and driving continuous