Join an Industry-Leading Team and Enhance Lives through Innovation 

Our client, a pioneering medical device company, is seeking a driven and skilled Quality Engineer to support their expanding team. Working under the guidance of the Senior Quality Manager, this position is central to ensuring product quality and regulatory compliance across all stages of development, manufacturing, and commercialisation. 

 This role offers an excellent opportunity to impact healthcare through high-quality medical devices, collaborating closely with R&D, manufacturing, and regulatory teams to deliver products that meet the highest standards. 

The position is based full time onsite on the Eastern side of Galway City, easily accessible. 

Key Responsibilities 

• Manufacturing Quality Support: Lead quality assurance efforts during in-house manufacturing, including overseeing lot release and ensuring compliance with rigorous standards. 

• Quality Management System Development: Contribute to the development and implementation of quality plans, programmes, and procedures for product commercialisation to build quality at every stage. 

• Regulatory Compliance: Ensure all work aligns with company quality policies and regulatory standards, supporting ISO 13485 and FDA CFR 820 requirements. 

• Quality Assurance & Reporting: Conduct thorough analysis and reporting on quality discrepancies, ensuring robust corrective actions for product design and manufacturing processes. 

• Supplier Quality Control: Collaborate with OEM contractors and vendors to maintain high quality standards across external component manufacturing. 

• Audit & Regulatory Support: Support FDA and Notified Body audits, assisting with compliance documentation and non-conformity responses as needed. 

 

Candidate Requirements 

• Educational Background: Bachelor’s degree in Engineering or Science is required; a Master’s or PhD is preferred. 

• Industry Experience: Minimum of 5 years’ experience in the medical device industry or equivalent through advanced study. 

• Technical Skills: Demonstrated expertise in medical device quality and regulatory systems, with essential knowledge of ISO 13485 and FDA CFR 820. 

• Additional Skills: Strong project planning, communication, and technical writing skills, with a fundamental understanding of engineering principles. 

• Preferred Knowledge: Familiarity with cleanroom and sterilisation procedures and prior experience with process validation are advantageous. 

 

Why Apply? 

This is a unique opportunity to join a dynamic, innovative team dedicated to improving patient outcomes and advancing healthcare technology. Our client offers a collaborative, entrepreneurial environment where Quality Engineers can make a meaningful impact on product excellence and patient safety. 

Ready to elevate your career while enjoying an outstanding quality of life in County Galway. Apply today to join this forward-thinking team! 

“Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie  

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/   

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. 

  

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.”