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
