Quality Engineer

About the Role

A fast-growing cardiovascular medical device company in Galway is seeking a Quality Engineer on a six-month contractual basis. The selected candidate will collaborate closely with Engineering, R&D, and Manufacturing teams to uphold product quality and ensure regulatory adherence throughout product development and production cycles.

Key Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) aligned with ISO 13485 standards and relevant regulatory guidelines.
• Work collaboratively with Research & Development, Manufacturing, and Engineering teams to embed quality requirements in all phases of product development and manufacturing.
• Support design control processes including conducting design reviews, creating verification and validation records, and managing design changes.
• Engage in risk management tasks such as Design Failure Mode and Effects Analysis (FMEA), Process FMEA, and comprehensive risk assessments.
• Evaluate and authorize quality-related documents including protocols, reports, procedures, and engineering modifications.
• Investigate deviations, customer complaints, and other quality-related issues, assisting with root cause analysis and executing corrective and preventive actions (CAPA).
• Participate in preparation for and conduct of internal, supplier, and external audits to maintain readiness.
• Assist supplier quality management through qualification processes, ongoing monitoring, and performance evaluations.
• Support validation activities for manufacturing processes and equipment qualification ensuring compliance with regulatory and quality standards.
• Track quality indicators and leverage findings to identify and pursue continuous improvement opportunities.
• Contribute to document management, training programs, and change control procedures.
• Ensure ongoing compliance with FDA Quality System Regulation, EU Medical Device Regulation, and other applicable standards.

Qualifications and Experience

• Bachelor's degree in Engineering or a related scientific field.
• Minimum three years of quality engineering experience in the medical device sector.
• Deep knowledge of ISO 13485 and medical device quality systems requirements.
• Practical experience with design controls and quality design activities.
• Proficiency in CAPA processes, non-conformance resolution, and root cause investigation.
• Hands-on experience supporting audit processes both internally and externally.
• Familiarity with FDA 21 CFR Part 820 and EU MDR regulations.
• Strong documentation, communication, and organizational capabilities.
• Ability to work autonomously while effectively functioning within cross-disciplinary teams.
• Previous exposure to Class III, cardiovascular, or catheter-based medical device technologies is a plus.
• Experience in start-up or early-stage medical device environments considered advantageous.

Additional Information

This position is a six-month contract based in Galway City and requires onsite presence.