Quality Engineer

Quality Engineer - Cork

About the Role

My client is seeking a Quality Engineer to support continuous improvement across products, processes, and materials. This role is ideal for someone early in their quality engineering career who is passionate about compliance, problem-solving, and driving high standards within a regulated manufacturing environment.

You will play a key role in maintaining and improving quality systems, supporting risk management activities, and ensuring products meet both internal and external standards.

Key Responsibilities

• Ensure compliance with internal and external quality standards for manufacturing and product development
• Support risk management activities across the product lifecycle, including pFMEA and dFMEA
• Assist in developing and maintaining quality documentation such as control plans, reports, and safety profiles
• Contribute to evaluations, testing, and decision-making to meet quality objectives
• Support investigations into non-conformities, deviations, and CAPA activities
• Assist with internal audits and process reviews to identify and resolve compliance issues
• Review Device History Records (DHRs) to ensure accuracy and completeness
• Support equipment calibration and maintenance programmes
• Participate in validation, transfer, and calibration activities (site-specific)
• Maintain and control quality documentation, ensuring revisions are properly communicated

Requirements

• Bachelor's degree in Engineering or a Science-related field
• 3-5 years' experience within the medical device or regulated industry
• Working knowledge of ISO 13485:2016 and FDA QSR requirements
• Understanding of ISO 17025:2017
• Strong analytical and problem-solving skills
• High attention to detail and strong organisational skills
• Proficiency in Microsoft Office (Word, Excel, Outlook)
• Excellent written and verbal communication skills
• Self-motivated with the ability to work independently