Quality Systems Engineer - Medical Devices, Pension

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 52,000 - 75,000; Full time

Benefits offered by this job

Pension

Healthcare

22 days annual leave

Job summary

Collins McNicholas Recruitment & HR Services Group is recruiting a Quality Engineer for a medical device manufacturer in Athlone. You will ensure QMS compliance and support audits to meet ISO 13485 and FDA 21 CFR Part 820.

The role emphasizes cross-functional collaboration, risk management, and continuous improvement across design, manufacture, and distribution of medical devices. A Bachelor’s degree and 3+ years in medical device quality are preferred.

Qualifications

• Bachelor’s degree in Science, Engineering or related discipline.
• 3+ years in Medical Device quality roles.
• Experience with ISO 13485 and FDA 21 CFR Part 820.

Responsibilities

• Support QMS compliance across FDA, ISO and global standards.
• Maintain quality system procedures, work instructions, and records.
• Monitor quality metrics and management reviews with CAPA activities.
• Lead root-cause investigations and corrective actions.
• Assist with risk management and design controls.
• Support internal audits, regulatory inspections and supplier quality.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Quality Systems

Auditing

Data Analysis

Education

Bachelor’s degree in Science/Engineering

Job description

Collins McNicholas Recruitment & HR Services Group is recruiting a Quality Engineer for a medical device manufacturer in Athlone. You will ensure QMS compliance and support audits to meet ISO 13485 and FDA 21 CFR Part 820.

The role emphasizes cross-functional collaboration, risk management, and continuous improvement across design, manufacture, and distribution of medical devices. A Bachelor’s degree and 3+ years in medical device quality are preferred.