Quality Technician - Medical Devices, CAPA & ISO13485

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 30,000 - 50,000; Full time

Job summary

Quasar Medical in Ireland is seeking a Quality Technician to support the quality system across manufacturing and product engineering, ensuring compliance with ISO13485, MDD 93/42/EEC and FDA QSR where applicable. You will review batch records, issue Certificates of Conformance and assist CAPA and internal audits.

The role emphasizes problem solving, process improvements, and collaboration with operations, QA and suppliers to maintain product quality and regulatory readiness.

Qualifications

• Experience in Medical Device industry is essential or highly desirable.
• 2–5 years of relevant experience in quality roles.
• Strong analytical and problem-solving abilities; able to influence improvements.

Responsibilities

• Review batch records and approve release of product and issue COCs/COAs.
• Support compliance with quality system requirements (ISO13485, MDD 93/42/EEC, FDA QSR).
• Assist CAPA investigations and internal/external audits.
• Support investigations into product defects and customer complaints.
• Participate in lean and cost-reduction activities.
• Maintain documentation for Site Production Department.

Skills

Interpersonal skills

Multi-tasking

Self-starter

Analytical thinking

Advanced communication

Cross-functional collaboration

Influence & change driving

Tools

IFS

SAP

Oracle

Job description

Quasar Medical in Ireland is seeking a Quality Technician to support the quality system across manufacturing and product engineering, ensuring compliance with ISO13485, MDD 93/42/EEC and FDA QSR where applicable. You will review batch records, issue Certificates of Conformance and assist CAPA and internal audits.

The role emphasizes problem solving, process improvements, and collaboration with operations, QA and suppliers to maintain product quality and regulatory readiness.