Quality Engineer - Medical Device Manufacturing

Location: Ballina, County Mayo, Ireland

A fantastic opportunity has arisen for a skilled Quality Engineer to join a leading medical device manufacturing company in the vibrant town of Ballina, County Mayo. This role offers the chance to work in a dynamic, quality-driven environment with a strong focus on continuous improvement and regulatory compliance. If you are passionate about quality assurance in the medical device sector and want to play an integral part in maintaining the highest standards, this could be the perfect next step in your career.

Key Responsibilities:

Non-Conforming Material Management: Actively participate in the evaluation and decision-making process for non-conforming materials, ensuring corrective actions are implemented effectively.

QMS Coordination: Take responsibility for coordinating essential Quality Management System (QMS) processes, including customer complaints, CAPA (Corrective and Preventive Action) systems, and internal audits at the Ballina site.

Documentation & Process Development: Create and maintain quality plans, work instructions, and other critical documents to support efficient, compliant operations.

Strategic Project Support: Contribute to key strategic projects, collaborating with cross-functional teams including Plant QA, Global Supplier Quality, Global Engineering, and Operations.

Defect Awareness Training: Facilitate training sessions to raise awareness and promote a culture of quality across the organisation.

Audit Participation: Engage in both internal and external audits, ensuring that all operations meet the required quality and regulatory standards.

Essential Functions:

Statistical Knowledge: Apply basic statistical tools and techniques to monitor and improve product quality.

Effective Communication: Exhibit strong written and verbal communication skills to liaise effectively with team members and stakeholders.

Technical Writing Expertise: Demonstrate proficiency in creating clear, concise, and accurate technical documentation.

Training & Facilitation: Lead training sessions and facilitate discussions to build a deeper understanding of quality processes across teams.

Regulatory Knowledge: Understanding of FDA (21 CFR 820) and ISO 13485 medical device regulations and Good Manufacturing Practices (GMP) is highly preferred.

Lean & Six Sigma Expertise: Knowledge of Lean and Six Sigma principles to identify and drive improvements in processes and product quality.

Team Collaboration: Work collaboratively with cross-functional teams to achieve quality objectives and drive continuous improvement.

Microsoft Office Proficiency: Be highly skilled in Microsoft Office Suite, including Word, Excel, PowerPoint, Project, and Access.

Education & Experience Requirements:

Experience: A minimum of 2-4 years’ experience in Quality Engineering or a related field. Experience in medical device manufacturing and knowledge of 21 CFR 820 and ISO 13485 is preferred.

Education: A degree in an Engineering or Science discipline, or related field, is desirable.

Why Join This Company?

This role provides an exciting opportunity to contribute to a leading medical device manufacturing company that values quality and innovation. The successful candidate will gain exposure to a range of cross-functional projects, ensuring personal and professional growth.

Living in County Mayo, Ireland

County Mayo offers a high quality of life, with stunning natural beauty, friendly communities, and a rich cultural heritage. Enjoy the peaceful surroundings, outdoor activities, and a thriving local economy. This is an excellent opportunity to balance career development with an excellent lifestyle.

 

Interested in applying?

If you are an experienced Quality Engineer ready to take the next step in your career, apply today for a chance to work with a forward-thinking company that values quality and continuous improvement.

“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.”