Senior Quality Engineer – Galway, Ireland 

About the Role: 

A fantastic opportunity has arisen for a Senior Quality Engineer to join a world-renowned leader in drug delivery devices, based in Galway, Ireland. This is a permanent position, reporting directly to the QA Manager. Due to the increased global demand for our client’s innovative products, this role offers the chance to be part of a dynamic team in a company that prioritises growth, career progression, and development opportunities. 

This is a Senior role that requires line management experience, the successful candidate must be a problem solver committed to leading the team day to day in a decisive and confident mannter. A minimum of 5 years' experience in a quality engineering role within a medical device manufacturing environment is a pre requisite.

Key Responsibilities: 

• Leadership & Ethos: The successful candidate will demonstrate strong leadership and establish a clear, identifiable work ethos within the Quality Engineering Team. 

• Process & Continuous Improvement: Lead the Quality Engineering team in supporting manufacturing processes, driving process enhancements, and promoting continuous improvement. 

• Data Analysis & Reporting: Perform data analysis and trending, assist with yield reporting, and conduct root cause analysis for quality issues in manufacturing. Manage quality-related Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs). 

• Quality Control & Compliance: Establish and maintain analysis techniques, quality control tools (such as SPC, Cpk, Ppk), and inspection plans for incoming materials and parts. Ensure compliance with ISO 13485 and FDA Quality System regulations. 

• Training & Resource Management: Develop, train, and manage the Quality Engineering support team to meet objectives and deliver within agreed requirements. 

• Documentation & Risk Management: Ensure timely closure of Quality System documentation, support Quality Management in strategy development, and drive risk management activities in manufacturing (Process FMECA). 

• GMP Standards & Compliance: Oversee GMP standards and compliance within the manufacturing area, ensuring all products meet defined specifications prior to shipment. 

Qualifications & Experience: 

• Educational Background: A Level 8 Bachelor’s degree in STEM. 

• Experience: At least 5 years of experience in a Quality Engineering capacity. 

• Communication Skills: Must possess strong communication skills, with the ability to engage effectively at all levels of the company. Experience liaising with suppliers, customers, and regulatory contacts in a professional manner is essential. 
• Industry Knowledge: Thorough understanding of ISO 13485 and FDA QSR is required. 

“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.”