Medical Device Quality Engineer – QMS & CAPA Lead

Hero Recruitment Group; Athlone; On-site; EUR 40,000 - 60,000; Full time

Benefits offered by this job

Health insurance after probation

Career development in medical device

Collaborative working environment

Opportunity to work on high-quality MD

Job summary

Hero Recruitment Group seeks a motivated Quality Engineer for its Athlone team in a highly regulated medical device environment.

The ideal candidate has 3–4 years of quality engineering experience, with practical knowledge of FDA QMS and ISO 13485, CAPA/NCR processes, and cross-functional collaboration with Manufacturing and Engineering. This on-site role offers growth within a strong quality culture.

Qualifications

• 3–4 years of quality engineering/QA experience in a regulated manufacturing environment.
• Bachelor’s or Master’s in a science or engineering discipline.
• Strong practical knowledge of FDA Quality System requirements and ISO 13485.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Support the maintenance and continuous improvement of the QMS in compliance with FDA requirements, ISO 13485 and applicable standards.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs, ensuring effective root cause analysis and timely closure.
• Support CAPA development, implementation and effectiveness monitoring.
• Assist internal and external audits, including preparation, responses and follow-up actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive process improvement.
• Support product and process risk assessments, validation, equipment qualification and other quality-related activities.
• Review and maintain QMS documentation and related quality records.
• Support supplier quality activities, supplier issues, corrective actions and performance monitoring.
• Support change control for product and process changes, ensuring quality requirements are met.
• Analyse quality data and trends to identify improvement opportunities and prevent recurring issues.

Skills

Problem-solving

Communication

Attention to detail

Cross-functional collaboration

Education

Science/Engineering degree (BSc/MSc)

Tools

Minitab

Q-Pulse

FDA QMS knowledge

Job description

Hero Recruitment Group seeks a motivated Quality Engineer for its Athlone team in a highly regulated medical device environment.

The ideal candidate has 3–4 years of quality engineering experience, with practical knowledge of FDA QMS and ISO 13485, CAPA/NCR processes, and cross-functional collaboration with Manufacturing and Engineering. This on-site role offers growth within a strong quality culture.