Quality Assurance Engineer - Medical Devices & QMS

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Pension

22 days annual leave

Job summary

Collins McNicholas Recruitment & HR Services Group is seeking a Quality Engineer for our medical device manufacturing client in Athlone. The role focuses on ensuring compliance of the QMS and products with FDA 21 CFR Part 820 and ISO 13485, by partnering with stakeholders and guiding quality processes.

The position supports internal processes and external audits to uphold product quality and patient safety through design, manufacture and distribution of medical devices.

Qualifications

• Bachelor’s Degree in a Science, Engineering, or related discipline.

Responsibilities

• Support QMS compliance with FDA/ISO and other global regulatory requirements.
• Maintain quality system procedures, work instructions, and records.
• Ensure QMS effectiveness via performance monitoring and management reviews.
• Lead and support CAPA processes and root cause investigations.
• Assist with risk management and design controls in quality processes.
• Coordinate internal audits and support regulatory inspections.
• Present quality metrics and trends to senior management.

Skills

Regulatory compliance

Quality systems

Audits

Data analysis

Education

Bachelor's Degree in Science or Engineering

Job description

Collins McNicholas Recruitment & HR Services Group is seeking a Quality Engineer for our medical device manufacturing client in Athlone. The role focuses on ensuring compliance of the QMS and products with FDA 21 CFR Part 820 and ISO 13485, by partnering with stakeholders and guiding quality processes.

The position supports internal processes and external audits to uphold product quality and patient safety through design, manufacture and distribution of medical devices.