Quality Engineer

Mason Alexander; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Mason Alexander in Galway is seeking a Quality Engineer for a 6-month contract to drive quality and regulatory compliance across development and manufacturing in a cardiovascular medical device setting.

You will collaborate with R&D, Engineering and Manufacturing to embed quality into product development, execute design controls, CAPA and risk assessments, and support audits and supplier quality to ensure compliance with ISO 13485 and EU MDR.

Qualifications

• 3 years of quality engineering experience in the medical device industry.
• Strong understanding of ISO 13485 and medical device quality systems.
• Experience with CAPA, non-conformance investigations and root cause analysis.
• Familiarity with FDA QSR (21 CFR Part 820) and EU MDR is advantageous.
• Experience supporting internal and external audits.

Responsibilities

• Support maintenance and continuous improvement of the QMS per ISO 13485 and regulatory requirements.
• Collaborate with R&D, Manufacturing, and Engineering to embed quality in development and manufacturing.
• Support design control activities including design reviews, verification, validation, and change management.
• Participate in risk management, including Design FMEA, Process FMEA and risk assessments.
• Review and approve quality documentation (protocols, reports, procedures, engineering changes).
• Investigate non-conformances and customer complaints; support root cause analysis and CAPA.
• Assist with supplier quality activities and audits; ensure audit readiness.
• Support process validation and equipment qualification activities.
• Monitor quality metrics and drive continuous improvement.
• Ensure compliance with regulatory standards.

Skills

Quality engineering

ISO 13485

CAPA

Design controls

Risk assessments

Audit support

Documentation

Cross-functional collaboration

Root cause analysis

Education

Engineering degree

Job description

A growing cardiovascular medical device company based in Galway is seeking a Quality Engineer to join its expanding team on a 6-month contract.

This is an exciting opportunity to join a growing, venture-backed medical device company where you will work closely with Engineering, R&D and Manufacturing to ensure product quality and regulatory compliance throughout product development and manufacturing.

The Quality Engineer will have the opportunity to contribute to the QMS, design quality activities, manufacturing support and supplier quality within an ISO 13485 regulated environment.

Responsibilities:

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements.
• Partner with R&D, Manufacturing and Engineering teams to ensure quality requirements are integrated throughout product development and manufacturing.
• Support design control activities including design reviews, design verification and validation documentation, and design change management.
• Participate in risk management activities including Design FMEA, Process FMEA and risk assessments.
• Review and approve quality documentation including protocols, reports, procedures and engineering changes.
• Investigate non-conformances, customer complaints and quality issues, supporting root cause analysis and CAPA implementation.
• Support internal, supplier and external audit activities and assist in maintaining audit readiness.
• Assist with supplier quality activities including supplier qualification, monitoring and performance reviews.
• Support process validation and equipment qualification activities, ensuring compliance with quality and regulatory requirements.
• Monitor quality metrics and identify opportunities for continuous improvement.
• Participate in document control, training and change management activities.
• Ensure compliance with FDA Quality System Regulation, EU MDR and other applicable regulatory standards.

Qualifications & Requirements Experience:

• Degree in Engineering, or a related scientific discipline.
• 3 years of quality engineering experience within the medical device industry.
• Strong understanding of ISO 13485 and medical device quality systems.
• Experience supporting Design Controls and Design Quality activities.
• Experience with CAPA, non-conformance investigations and root cause analysis.
• Experience supporting internal and external audits.
• Understanding of FDA Quality System Regulation (21 CFR Part 820) and EU Medical Device Regulation (EU MDR).
• Excellent documentation, communication and organisational skills.
• Ability to work independently while collaborating effectively within multidisciplinary teams.
• Previous experience within Class III, cardiovascular or catheter-based medical devices would be an advantage.
• Experience working in a start-up or early-stage medical device company would be highly desirable.

This is a 6 month contract based in Galway City.